Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
An 8-week Randomized, Double Blind, Multi-center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin ( 300mg/Day ) Using A Fixed Dosing Schedule In The Treatment Of Subjects With Postherpetic Neuralgia ( Phn )
1 other identifier
interventional
223
1 country
22
Brief Summary
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2011
Typical duration for phase_4
22 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
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
May 22, 2015
CompletedJanuary 28, 2021
May 1, 2015
2.1 years
October 17, 2011
January 8, 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 until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Secondary Outcomes (23)
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8
Baseline and weekly from Weeks 1 to 8
Baseline Mean Sleep Interference Score
Baseline
Change From Baseline in Mean Sleep Interference Score at Endpoint
Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8
Baseline and weekly from Weeks 1 to 8
Percentage of 30 Percent (%) Responders at Endpoint
End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
- +18 more secondary outcomes
Study Arms (2)
Lyrica (pregabalin)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female Chinese subjects, ages ≥18 at screening
- Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ﹥3 months after healing of the acute herpes zoster skin rash
- At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
- At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
- At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days
You may not qualify if:
- Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain Visual Analog Scale (VAS) at randomization as compared to screening
- Subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ﹥3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Neurology Department, Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Second Affiliated Hospital of Soochow University/Neurology Department
Suzhou, Jiangsu, 215004, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept.
Hangzhou, Zhejiang, 310003, China
Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept.
Hangzhou, Zhejiang, 310016, China
Beijing Friendship Hospital, Capital Medical University/Department of Internal Neurology
Beijing, 100050, China
Peking University Third Hospital, Neurology Department
Beijing, 100191, China
Neurology Department, Beijing Hospital of the Ministry of Health
Beijing, 100730, China
West China Hospital of Sichuan University, Neurology Department
Chengdu/wuhou D, 610041, China
the first affiliated hospital ,chongqing medical university, Department of Neurology
Chongqing, 400016, China
GuangZhou First Municipal People's Hospital
Guangzhou, 510180, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, 510630, China
Neurology Department, Shanghai Changzheng Hospital
Shanghai, 200003, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Huashan Hospital, Fudan University/Neurology Department
Shanghai, 200040, China
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
Shanghai, 200127, China
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, 300052, 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 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2011
First Posted
October 20, 2011
Study Start
December 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
January 28, 2021
Results First Posted
May 22, 2015
Record last verified: 2015-05