Status:
COMPLETED
Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Postherpetic Neuralgia ( PHN )
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01455428
Start Date
December 1 2011
End Date
January 1 2014
Last Update
January 28 2021
Active Locations (22)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
3
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
4
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022