Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01455428
First received: October 17, 2011
Last updated: May 30, 2013
Last verified: May 2013
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Purpose
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
| Condition | Intervention | Phase |
|---|---|---|
|
Postherpetic Neuralgia ( PHN ) |
Drug: Lyrica (pregabalin) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 Patients With Postherpetic Neuralgia (PHN) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Endpoint change from baseline in weekly mean pain score based on the Daily Pain Rating Scale (DPRS) from the subject's daily pain diary [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in weekly mean pain scores from the subject's daily pain diary ratings [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in weekly mean sleep interference scores from the subject's daily sleep diary [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Responder rates (defined as the proportion of subjects reporting a decrease at least 30% from baseline in weekly mean pain score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Pain Visual Analogue Scale (VAS) from the SF-MPQ [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Present Pain Intensity (PPI) Scale from the SF-MPQ [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Medical Outcomes Study (MOS)-Sleep scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression of Change (CGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Subject Global Impression of Change (PGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 218 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lyrica (pregabalin) |
Drug: Lyrica (pregabalin)
Capsule, 300 mg/d, BID, 8 weeks treatment
|
| Placebo Comparator: Placebo |
Drug: Placebo
Capsule, 300 mg/d, BID, 8 weeks treatment
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455428
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| China, Guangdong | |
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Recruiting |
| Guangzhou, Guangdong, China, 510120 | |
| Shenzhen People's Hospital | Recruiting |
| Shenzhen, Guangdong, China, 518020 | |
| China, Hubei | |
| Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology | Recruiting |
| Wuhan, Hubei, China, 430030 | |
| China, Jiangsu | |
| Neurology Department, Jiangsu Province Hospital | Recruiting |
| Nanjing, Jiangsu, China, 210029 | |
| The Second Affiliated Hospital of Soochow University/Neurology Department | Recruiting |
| Suzhou, Jiangsu, China, 215004 | |
| China, Shandong | |
| Qilu Hospital of Shandong University | Recruiting |
| Jinan, Shandong, China, 250012 | |
| China, Zhejiang | |
| Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept. | Recruiting |
| Hangzhou, Zhejiang, China, 310016 | |
| The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept. | Recruiting |
| Hangzhou, Zhejiang, China, 310003 | |
| China | |
| Neurology Department, Beijing Hospital of the Ministry of Health | Recruiting |
| Beijing, China, 100730 | |
| Beijing Friendship Hospital, Capital Medical University/Department of Internal Neurology | Recruiting |
| Beijing, China, 100050 | |
| Peking University Third Hospital, Neurology Department | Recruiting |
| Beijing, China, 100191 | |
| West China Hospital of Sichuan University, Neurology Department | Recruiting |
| Chengdu/wuhou D, China, 610041 | |
| the first affiliated hospital ,chongqing medical university, Department of Neurology | Recruiting |
| Chongqing, China, 400016 | |
| GuangZhou First Municipal People's Hospital | Recruiting |
| Guangzhou, China, 510180 | |
| The Third Affiliated Hospital of Sun Yat-sen University | Not yet recruiting |
| Guangzhou, China, 510630 | |
| Neurology Department, Shanghai Changzheng Hospital | Recruiting |
| Shang Hai, China, 200003 | |
| Huashan Hospital, Fudan University/Neurology Department | Recruiting |
| Shang Hai, China, 200040 | |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting |
| Shanghai, China, 200025 | |
| Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department | Recruiting |
| Shanghai, China, 200127 | |
| Tianjin Medical University General Hospital, Dermatological Department | Recruiting |
| Tianjin, China, 300052 | |
| Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Recruiting |
| Wuahn, China, 430022 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01455428 History of Changes |
| Other Study ID Numbers: | A0081276 |
| Study First Received: | October 17, 2011 |
| Last Updated: | May 30, 2013 |
| Health Authority: | China: State Food and Drug Adminstration |
Keywords provided by Pfizer:
|
Pregabalin Postherpetic Neuralgia ( PHN ) |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Pregabalin |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on June 18, 2013