Diabetic Neuropathy, PainfulPhase 3NCT00553475

Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

A Phase 3 study testing pregabalin in people with Diabetic Neuropathy, Painful, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 49 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Neuropathy, Painful
What is being tested?: pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 314 participants
Where: 49 sitesJapan
Study dates: Oct 2007to Mar 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Visual Analogue Scale (VAS) of pain is higher than 40 mm.
Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Who cannot join

Malignancy within the past 2 years.
Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain

Trial locations and contacts

49 sites in 1 country.

City, postcode or hospital

49 sites in 1 country

Japan49 sites

Pfizer Investigational Site
Arakawa City, Tokyo
Pfizer Investigational Site
Beppu, Oita Prefecture
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Chikushino-shi, Fukuoka
Pfizer Investigational Site
Chitose, Hokkaido
Pfizer Investigational Site
Chiyoda-ku, Tokyo
Pfizer Investigational Site
Chuo-ku, Tokyo
Pfizer Investigational Site
Date-shi, Fukushima
Pfizer Investigational Site
Ebetu, Hokkaido
Pfizer Investigational Site
Fukuoka
Pfizer Investigational Site
Higashiosaka, Osaka
Pfizer Investigational Site
Hirano-ku, Osaka
Pfizer Investigational Site
Inashiki, Ibaraki
Pfizer Investigational Site
Kamakura, Kanagawa
Pfizer Investigational Site
Kasuga, Fukuoka
Pfizer Investigational Site
Kishiwada, Osaka
Pfizer Investigational Site
Kobe, Hyōgo
Pfizer Investigational Site
Kumamoto
Pfizer Investigational Site
Kure, Hiroshima
Pfizer Investigational Site
Matsumoto, Nagano
Pfizer Investigational Site
Minato-ku, Tokyo
Pfizer Investigational Site
Nagasaki
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Naha, Okinawa
Pfizer Investigational Site
Nihommatsu, Fukushima
Pfizer Investigational Site
Niigata
Pfizer Investigational Site
Nishitōkyō, Tokyo
Pfizer Investigational Site
Ohta-ku, Tokyo
Pfizer Investigational Site
Ōita
Pfizer Investigational Site
Okayama
Pfizer Investigational Site
Oyama-shi, Tochigi
Pfizer Investigational Site
Saga
Pfizer Investigational Site
Saitama
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Sapporo, Hokkaiido
Pfizer Investigational Site
Sendai, Miyagi
Pfizer Investigational Site
Shibuya-ku, Tokyo
Pfizer Investigational Site
Shirakawa-shi, Fukushima
Pfizer Investigational Site
Sukagawa, Fukushima
Pfizer Investigational Site
Suminoe-ku, Osaka
Pfizer Investigational Site
Sunto-gun, Shizuoka
Pfizer Investigational Site
Tokushima
Pfizer Investigational Site
Tomishiro, Okinawa
Pfizer Investigational Site
Ueda, Nagano
Pfizer Investigational Site
Urazoe, Okinawa
Pfizer Investigational Site
Utsunomiya, Tochigi
Pfizer Investigational Site
Yamada, Okayama-ken
Pfizer Investigational Site
Yatsushiro, Kumamoto
Pfizer Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

Conditions: Diabetic Neuropathy, Painful
Being tested: placebo, pregabalin
Medical subject headings: Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
pregabalinDrug
Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
pregabalinDrug
Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

Study groups in NCT00553475
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: placebo
Pregabalin 300 mg/day	Experimental	Not described Receives: Drug: pregabalin
Pregabalin 600 mg/day	Experimental	Not described Receives: Drug: pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Number of Responders
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline at Week 1 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.
Change from baseline: Score at Week 1 minus score at baseline
Measured: From baseline to Week 1
Change From Baseline at Week 2 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.
Change from baseline: Score at Week 2 minus score at baseline
Measured: From baseline to Week 2
Change From Baseline at Week 3 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.
Change from baseline: Score at Week 3 minus score at baseline
Measured: From baseline to Week 3
Change From Baseline at Week 4 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.
Change from baseline: Score at Week 4 minus score at baseline
Measured: From baseline to Week 4
Change From Baseline at Week 5 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.
Change from baseline: Score at Week 5 minus score at baseline
Measured: From baseline to Week 5
Change From Baseline at Week 6 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.
Change from baseline: Score at Week 6 minus score at baseline
Measured: From baseline to Week 6
Change From Baseline at Week 7 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.
Change from baseline: Score at Week 7 minus score at baseline
Measured: From baseline to Week 7
Change From Baseline at Week 8 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.
Change from baseline: Score at Week 8 minus score at baseline
Measured: From baseline to Week 8
Change From Baseline at Week 9 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.
Change from baseline: Score at Week 9 minus score at baseline
Measured: From baseline to Week 9
Change From Baseline at Week 10 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.
Change from baseline: Score at Week 10 minus score at baseline
Measured: From baseline to Week 10
Change From Baseline at Week 11 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.
Change from baseline: Score at Week 11 minus score at baseline
Measured: From baseline to Week 11
Change From Baseline at Week 12 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.
Change from baseline: Score at Week 12 minus score at baseline
Measured: From baseline to Week 12
Change From Baseline at Week 13 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.
Change from baseline: Score at Week 13 minus score at baseline
Measured: From baseline to Week 13

Secondary outcomes (23)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Mean Sleep Interference Scores
The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.
Measured: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Clinical Global Impression of Change
Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: Week 13 or up to discontinuation
Patient Global Impression of Change
The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: Week 13 or up to discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Mar 2009

First posted5 Nov 2007 (estimated)
Study startOct 2007
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Diabetic Neuropathy, PainfulStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 314 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00553475
Sponsor's protocol ID: A0081163
Status last verified: Jul 2010
First submitted: 2 Nov 2007
Last updated: 25 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.
PubMed 31802967
Alexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018.
PubMed 30521533
Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11.
PubMed 30206821
Parsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20.
PubMed 30084288
Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
PubMed 27611736

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy

All Diabetic Neuropathy, Painful trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy
ClinicalTrials.gov ID: NCT00553475
Acronym / sponsor ID: A0081163
Conditions: Diabetic Neuropathy, Painful
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 314 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 5 Nov 2007 (estimated)
Results: Posted 22 Jun 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placebo
Pregabalin 300 mg/day	Experimental	Drug: pregabalin
Pregabalin 600 mg/day	Experimental	Drug: pregabalin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Visual Analogue Scale (VAS) of pain is higher than 40 mm.
Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Key exclusion criteria (2 listed)

Malignancy within the past 2 years.
Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placeboDosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)	Drug	Placebo
pregabalinDosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)	Drug	Pregabalin 300 mg/day
pregabalinDosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)	Drug	Pregabalin 600 mg/day

Primary outcome

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).
Number of Responders
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.
Change From Baseline at Week 1 in Mean Weekly Pain Scores
Time frame: From baseline to Week 1
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1. Change from baseline: Score at Week 1 minus score at baseline
Change From Baseline at Week 2 in Mean Weekly Pain Scores
Time frame: From baseline to Week 2
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2. Change from baseline: Score at Week 2 minus score at baseline
Change From Baseline at Week 3 in Mean Weekly Pain Scores
Time frame: From baseline to Week 3
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3. Change from baseline: Score at Week 3 minus score at baseline
Change From Baseline at Week 4 in Mean Weekly Pain Scores
Time frame: From baseline to Week 4
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4. Change from baseline: Score at Week 4 minus score at baseline
Change From Baseline at Week 5 in Mean Weekly Pain Scores
Time frame: From baseline to Week 5
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5. Change from baseline: Score at Week 5 minus score at baseline
Change From Baseline at Week 6 in Mean Weekly Pain Scores
Time frame: From baseline to Week 6
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6. Change from baseline: Score at Week 6 minus score at baseline
Change From Baseline at Week 7 in Mean Weekly Pain Scores
Time frame: From baseline to Week 7
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7. Change from baseline: Score at Week 7 minus score at baseline
Change From Baseline at Week 8 in Mean Weekly Pain Scores
Time frame: From baseline to Week 8
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8. Change from baseline: Score at Week 8 minus score at baseline
Change From Baseline at Week 9 in Mean Weekly Pain Scores
Time frame: From baseline to Week 9
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9. Change from baseline: Score at Week 9 minus score at baseline
Change From Baseline at Week 10 in Mean Weekly Pain Scores
Time frame: From baseline to Week 10
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10. Change from baseline: Score at Week 10 minus score at baseline
Change From Baseline at Week 11 in Mean Weekly Pain Scores
Time frame: From baseline to Week 11
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11. Change from baseline: Score at Week 11 minus score at baseline
Change From Baseline at Week 12 in Mean Weekly Pain Scores
Time frame: From baseline to Week 12
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12. Change from baseline: Score at Week 12 minus score at baseline
Change From Baseline at Week 13 in Mean Weekly Pain Scores
Time frame: From baseline to Week 13
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13. Change from baseline: Score at Week 13 minus score at baseline

23 secondary outcomes

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Mean Sleep Interference Scores
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Clinical Global Impression of Change
Time frame: Week 13 or up to discontinuation
Patient Global Impression of Change
Time frame: Week 13 or up to discontinuation

Results and safety

Results posted to the registry on 22 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	135	119
Pregabalin 300 mg/Day	134	114
Pregabalin 600 mg/Day	45	32

Primary outcome: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint). Least squares mean (Standard Error). Unit: score on scale

Measure	Placebo n = 135	Pregabalin 300 mg/Day n = 134	Pregabalin 600 mg/Day n = 45
Value	-1.20 (0.21)	-1.82 (0.22)	-1.94 (0.32)

Placebo vs Pregabalin 300 mg/Day: Mean Difference (Final Values): -0.63 (95% CI -1.09 to -0.17), p = 0.0075, ANCOVA
Placebo vs Pregabalin 600 mg/Day: Mean Difference (Final Values): -0.74 (95% CI -1.39 to -0.09), p = 0.0254, ANCOVA

Population analysed: Full analysis set. Last observation carried forward.

Primary outcome: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint). Least squares mean (Standard Error). Unit: score on scale

Measure	Placebo n = 135	Expected Exposure Pregabalin 300 mg/Day n = 120	Expected Exposure Pregabalin 600 mg/Day n = 59
Value	-1.27 (0.16)	-1.93 (0.17)	-1.90 (0.25)

Placebo vs Expected Exposure Pregabalin 300 mg/Day: Mean Difference (Final Values): -0.67 (95% CI -1.14 to -0.19), p = 0.0058, ANCOVA
Placebo vs Expected Exposure Pregabalin 600 mg/Day: Mean Difference (Final Values): -0.64 (95% CI -1.23 to -0.05), p = 0.0333, ANCOVA

Population analysed: Full analysis set. Last observation carried forward.

Primary outcome: Number of Responders

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint). Number. Unit: participants

Measure	Placebo n = 135	Pregabalin 300 mg/Day n = 134	Pregabalin 600 mg/Day n = 45
Value	29	39	16

Placebo vs Pregabalin 300 mg/Day: p = 0.153, Cochran-Mantel-Haenszel
Placebo vs Pregabalin 600 mg/Day: p = 0.059, Cochran-Mantel-Haenszel

Population analysed: Full analysis set. Last observation carried forward.

Primary outcome: Change From Baseline at Week 1 in Mean Weekly Pain Scores

Time frame: From baseline to Week 1. Least squares mean (Standard Error). Unit: score on scale

Measure	Placebo n = 135	Pregabalin 300 mg/Day n = 134	Pregabalin 600 mg/Day n = 45
Value	-0.39 (0.17)	-0.82 (0.17)	-1.14 (0.26)

Placebo vs Pregabalin 300 mg/Day: Mean Difference (Final Values): -0.43 (95% CI -0.82 to -0.05), p = 0.0287, Mixed Model Repeated Measures Analysis
Placebo vs Pregabalin 600 mg/Day: Median Difference (Final Values): -0.75 (95% CI -1.29 to -0.20), p = 0.0073, Mixed Model Repeated Measures Analysis

Population analysed: Full analysis set. Observed case (No imputation).

23 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 135 (2.2%)	50 of 135 (37%)	Not reported
Pregabalin 300 mg/Day	2 of 134 (1.5%)	71 of 134 (53%)	Not reported
Pregabalin 600 mg/Day	1 of 45 (2.2%)	36 of 45 (80%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31802967Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.
Derived from this study: PubMed 30521533Alexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018.
Derived from this study: PubMed 30206821Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11.
Derived from this study: PubMed 30084288Parsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20.
Derived from this study: PubMed 27611736Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

49 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pregabalin in people with Diabetic Neuropathy, Painful, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 49 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00553475, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.