Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
NCT01455428
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN) | |||
Official Title ICMJE | 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 ) | |||
Brief Summary | To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Postherpetic Neuralgia ( PHN ) | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 223 | |||
Original Estimated Enrollment ICMJE | 218 | |||
Actual Study Completion Date ICMJE | January 2014 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01455428 | |||
Other Study ID Numbers ICMJE | A0081276 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |