Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
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.
1 other identifier
interventional
626
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2011
Typical duration for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2011
CompletedFirst Posted
Study publicly available on registry
April 8, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
June 19, 2015
CompletedJanuary 28, 2021
June 1, 2015
2.8 years
April 7, 2011
March 23, 2015
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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
Baseline and weekly from Weeks 1 to 9
Baseline Mean Sleep Interference Score
Baseline
Change From Baseline in Mean Sleep Interference Score at Endpoint
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
Baseline and weekly from Weeks 1 to 9
Percentage of 30 Percent (%) Responders at Endpoint
End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
- +18 more secondary outcomes
Study Arms (2)
300 mg/day pregabalin (Lyrica)
EXPERIMENTALPatient take pregabalin capsule twice a day
Placebo
PLACEBO COMPARATORInterventions
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.
Subject will take placebo matched with pregabalin twice a day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Southwest hospital of the third military medical university/Department of Neurology
Chongqing, Chongqing Municipality, 400038, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, 350025, China
Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Xiangya Hospital of Centre-south University
Changsha, Hunan, 410008, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Dept. of Endocrinology, The second hospital of Jilin University
Changchun, Jilin, 130041, China
Shengjing hospital of china medical university
Shenyang, Liaoning, 110004, China
Qilu Hospital of Shandong University/department of internal neurology
Jinan, Shandong, 250012, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital, School of medicine, Zhejiang University
Hangzhou, Zhejiang, 310016, China
Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department
Beijing, 100050, China
Peking University Third Hospital
Beijing, 100191, China
Endocrinology Department
Beijing, 100700, China
Beijing Hospital of the Ministry of Health
Beijing, 100730, China
Tongren Hospital Affiliated to Capital Medical University
Beijing, 100730, China
Chinese PLA General Hospital
Beijing, 100853, China
GuangZhou First Municipal People's Hospital
Guangzhou, 510180, China
Shanghai Changzheng Hospital
Shanghai, 200003, China
Huashan Hospital Affiliated Fudan University, Neurology Department
Shanghai, 200040, China
Shanghai Tenth People's Hospital/The Endocrinology Department
Shanghai, 200072, China
Shanghai First People's Hospital
Shanghai, 200080, China
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
Shanghai, 200127, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2011
First Posted
April 8, 2011
Study Start
July 1, 2011
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
January 28, 2021
Results First Posted
June 19, 2015
Record last verified: 2015-06