Diabetic Neuropathy, PainfulPhase 3NCT00553280

A Long-Term Study To Evaluate Safety And Efficacy 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 27 sites in Japan.

Completed

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

Official record

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Trial summary

The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163 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?: No, everyone receives an active treatment
How many people: 123 participants
Where: 27 sitesJapan
Study dates: Feb 2008to Jan 2010
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

Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A0081163.
Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study

Who cannot join

Patients who experienced serious adverse events in the preceding study (A0081163) that were determined by the investigator or the study sponsor to be causally related to the study medication.
Patients exhibiting treatment non-compliance in the preceding study (A0081163)

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

Japan27 sites

Pfizer Investigational Site
Arakawa City, Tokyo
Pfizer Investigational Site
Beppu, Oita Prefecture
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Chiyoda-ku, Tokyo
Pfizer Investigational Site
Date-shi, Fukushima
Pfizer Investigational Site
Fukuoka
Pfizer Investigational Site
Hirano-ku, Osaka
Pfizer Investigational Site
Kamakura, Kanagawa
Pfizer Investigational Site
Matsumoto, Nagano
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Naha, Okinawa
Pfizer Investigational Site
Nihommatsu, Fukushima
Pfizer Investigational Site
Ohta-ku, Tokyo
Pfizer Investigational Site
Ōita
Pfizer Investigational Site
Oyama-shi, Tochigi
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
Yamada, Okayama-ken
Pfizer Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

Conditions: Diabetic Neuropathy, Painful
Being tested: 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.

pregabalinDrug
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Study groups in NCT00553280
Study group	Role	What they receive
pregabalin	Experimental	Not described Receives: Drug: pregabalin

What is being measured

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

Summary of Adverse Events
Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.
Measured: 53 weeks

Secondary outcomes (5)

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 52 weeks or 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 52 weeks or 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 52 weeks or 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 52 weeks or 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 52 weeks or study discontinuation (Study Endpoint)

Timeline

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

Feb 2008Jan 2010

First posted5 Nov 2007 (estimated)
Study startFeb 2008
Primary completionJan 2010
Study completionJan 2010

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 (2)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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00553280
Sponsor's protocol ID: A0081164
Status last verified: Apr 2011
First submitted: 2 Nov 2007
Last updated: 25 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.
PubMed 27448285
Satoh J, Yagihashi S, Baba M, Suzuki M, Arakawa A, Yoshiyama T. Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial. J Diabetes Investig. 2011 Nov 30;2(6):457-63. doi: 10.1111/j.2040-1124.2011.00122.x.
PubMed 24843530

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

RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
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

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: An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy
ClinicalTrials.gov ID: NCT00553280
Acronym / sponsor ID: A0081164
Conditions: Diabetic Neuropathy, Painful
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 5 Nov 2007 (estimated)
Results: Posted 5 Jan 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
pregabalin	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)

Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A0081163.
Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study

Key exclusion criteria (2 listed)

Patients who experienced serious adverse events in the preceding study (A0081163) that were determined by the investigator or the study sponsor to be causally related to the study medication.
Patients exhibiting treatment non-compliance in the preceding study (A0081163)

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
pregabalinDosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks	Drug	pregabalin

Primary outcome

Summary of Adverse Events
Time frame: 53 weeks
Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.

5 secondary outcomes

Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)

Results and safety

Results posted to the registry on 5 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	123	97

Primary outcome: Summary of Adverse Events

Time frame: 53 weeks. Number. Unit: participants

Measure	Pregabalin n = 123
Participants with adverse events	114
Participants with serious adverse events	21
Participants with severe adverse events	7
Participants discontinued due to adverse events	17
Dose reduced or temporary discontinuation	43

Population analysed: Safety analysis set: all participants who had received at least one dose of the study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 53 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	21 of 123 (17.1%)	101 of 123 (82.1%)	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 27448285Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.
Derived from this study: PubMed 24843530Satoh J, Yagihashi S, Baba M, Suzuki M, Arakawa A, Yoshiyama T. Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial. J Diabetes Investig. 2011 Nov 30;2(6):457-63. doi: 10.1111/j.2040-1124.2011.00122.x.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Diabetic Neuropathy, Painful

RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
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

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

27 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 27 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 27 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. 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 5 Jan 2011). 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?

Summary of Adverse Events (time frame: 53 weeks). 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 NCT00553280, which also lists 2 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.