Diabetic Neuropathy, PainfulPhase 3NCT01332149
Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful 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 30 sites in China.
Trial summary
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic 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
- 626 participants
- Where
- 30 sitesChina
- Study dates
- Jul 2011to Jun 2014
- 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
- Male and female subjects aged 18 years or older
- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
- At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
- Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Women of childbearing potential are willing to use contraception during study.
Who cannot join
- Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score <3 in pain scores.
- Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
- Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites
Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department
Beijing, 100050
Peking University Third Hospital
Beijing, 100191
Endocrinology Department
Beijing, 100700
Beijing Hospital of the Ministry of Health
Beijing, 100730
Tongren Hospital Affiliated to Capital Medical University
Beijing, 100730
Chinese PLA General Hospital
Beijing, 100853
Dept. of Endocrinology, The second hospital of Jilin University
Changchun, Jilin, 130041
Xiangya Hospital of Centre-south University
Changsha, Hunan, 410008
Southwest hospital of the third military medical university/Department of Neurology
Chongqing, Chongqing Municipality, 400038
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, 350025
Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
GuangZhou First Municipal People's Hospital
Guangzhou, 510180
The Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital, School of medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Qilu Hospital of Shandong University/department of internal neurology
Jinan, Shandong, 250012
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Shanghai Changzheng Hospital
Shanghai, 200003
Huashan Hospital Affiliated Fudan University, Neurology Department
Shanghai, 200040
Shanghai Tenth People's Hospital/The Endocrinology Department
Shanghai, 200072
Shanghai First People's Hospital
Shanghai, 200080
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
Shanghai, 200127
Shengjing hospital of china medical university
Shenyang, Liaoning, 110004
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, 430030
About this study
Official title: An 11-week Randomized, Double-blind, Multi Center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (300 Mg/Day) Using A Fixed Dosing Schedule In The Treatment Of Subjects S With Pain Associated With Diabetic Peripheral Neuropathy.
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.
This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- Pregabalin, Placebo matched with pregabalin
- Keywords
- Diabetic Neuropathies, Pain, Efficacy of pregabalin, Placebo controlled
- Medical subject headings
- Diabetic Neuropathies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.
At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day.
Placebo matched with pregabalinDrug
Subject will take placebo matched with pregabalin twice a day.
| Study group | Role | What they receive |
|---|---|---|
| 300 mg/day pregabalin (Lyrica) | Experimental | Patient take pregabalin capsule twice a day Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo matched with pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Mean Pain Score
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Measured: Baseline
Change From Baseline in Mean Pain Score at Endpoint
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
Measured: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
Secondary outcomes (23)
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9
The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.
Measured: Baseline and weekly from Weeks 1 to 9
Baseline Mean Sleep Interference Score
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.
Measured: Baseline
Change From Baseline in Mean Sleep Interference Score at Endpoint
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 9 (Day 63) dose.
Measured: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.
Measured: Baseline and weekly from Weeks 1 to 9
Percentage of 30 Percent (%) Responders at Endpoint
The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 63/Week 9) (Study Endpoint) compared to baseline.
Measured: End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9
SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.
Measured: Baseline; Weeks 1, 5, and 9
Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale
The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Measured: Baseline
Change From Baseline in Pain VAS From the SF-MPQ at Endpoint
The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in PPI Scale From the SF-MPQ at Endpoint
The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores
The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity [range 0-24 hours], optimal sleep [yes:1, no:0]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep).
Measured: Baseline
Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Percentage of Participants Who Had Optimal Sleep at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.
Measured: Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Clinical Global Impression of Change (CGIC) at Endpoint
The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Measured: Day 63 (Week 9)/Early Termination (Study Endpoint)
Patient Global Impression of Change (PGIC) Score at Endpoint
The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Measured: Day 63 (Week 9)/Early Termination (Study Endpoint)
Baseline Hospital Anxiety and Depression Scale (HADS) Scores
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Measured: Baseline
Change From Baseline in HADS Anxiety Total Score at Endpoint
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in HADS Depression Total Score at Endpoint
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Measured: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2014
- Study completionJun 2014
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.
- 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
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332149
- Sponsor's protocol ID
- A0081265
- Status last verified
- Jun 2015
- First submitted
- 7 Apr 2011
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 11-week Randomized, Double-blind, Multi Center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (300 Mg/Day) Using A Fixed Dosing Schedule In The Treatment Of Subjects S With Pain Associated With Diabetic Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT01332149
- Acronym / sponsor ID
- A0081265
- Conditions
- Diabetic Neuropathy, Painful
- Keywords
- Diabetic Neuropathies, Pain, Efficacy of pregabalin, Placebo controlled
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Posted 19 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.
This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300 mg/day pregabalin (Lyrica) | Experimental | Drug: PregabalinPatient take pregabalin capsule twice a day |
| Placebo | Placebo comparator | Drug: Placebo matched with pregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged 18 years or older
- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
- At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
- Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Women of childbearing potential are willing to use contraception during study.
Key exclusion criteria (3 listed)
- Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score <3 in pain scores.
- Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
- Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
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 |
|---|---|---|
| PregabalinSubjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn. At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day. | Drug | 300 mg/day pregabalin (Lyrica) |
| Placebo matched with pregabalinSubject will take placebo matched with pregabalin twice a day. | Drug | Placebo |
Primary outcome
Baseline Mean Pain Score
Time frame: Baseline
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Change From Baseline in Mean Pain Score at Endpoint
Time frame: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
23 secondary outcomes
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9
Time frame: Baseline and weekly from Weeks 1 to 9
Baseline Mean Sleep Interference Score
Time frame: Baseline
Change From Baseline in Mean Sleep Interference Score at Endpoint
Time frame: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9
Time frame: Baseline and weekly from Weeks 1 to 9
Percentage of 30 Percent (%) Responders at Endpoint
Time frame: End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9
Time frame: Baseline; Weeks 1, 5, and 9
Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale
Time frame: Baseline
Change From Baseline in Pain VAS From the SF-MPQ at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in PPI Scale From the SF-MPQ at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores
Time frame: Baseline
Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Percentage of Participants Who Had Optimal Sleep at Endpoint
Time frame: Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Clinical Global Impression of Change (CGIC) at Endpoint
Time frame: Day 63 (Week 9)/Early Termination (Study Endpoint)
Patient Global Impression of Change (PGIC) Score at Endpoint
Time frame: Day 63 (Week 9)/Early Termination (Study Endpoint)
Baseline Hospital Anxiety and Depression Scale (HADS) Scores
Time frame: Baseline
Change From Baseline in HADS Anxiety Total Score at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Change From Baseline in HADS Depression Total Score at Endpoint
Time frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Painful Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain (DPN)
Recruiting
Neurofeedback for the Management of Neuropathic Pain in People With Diabetes
Neuropathy, Painful Diabetic
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
30 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 30 sites in China.
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 5 inclusion and 3 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 28 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 30 sites in China. 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 19 Jun 2015). 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?
Baseline Mean Pain Score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.