Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01455428
First received: October 17, 2011
Last updated: March 24, 2014
Last verified: March 2014
  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 ]

Enrollment: 224
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455428

Locations
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
China, Guangdong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
China, Hubei
Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
China, Jiangsu
Neurology Department, Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
The Second Affiliated Hospital of Soochow University/Neurology Department
Suzhou, Jiangsu, China, 215004
China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept.
Hangzhou, Zhejiang, China, 310003
Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept.
Hangzhou, Zhejiang, China, 310016
China
Neurology Department, Beijing Hospital of the Ministry of Health
Beijing, China, 100730
Beijing Friendship Hospital, Capital Medical University/Department of Internal Neurology
Beijing, China, 100050
Peking University Third Hospital, Neurology Department
Beijing, China, 100191
West China Hospital of Sichuan University, Neurology Department
Chengdu/wuhou D, China, 610041
the first affiliated hospital ,chongqing medical university, Department of Neurology
Chongqing, China, 400016
GuangZhou First Municipal People's Hospital
Guangzhou, China, 510180
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China, 510630
Neurology Department, Shanghai Changzheng Hospital
Shang Hai, China, 200003
Huashan Hospital, Fudan University/Neurology Department
Shang Hai, China, 200040
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
Shanghai, China, 200127
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, China, 300052
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
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: March 24, 2014
Health Authority: United States: Food and Drug Administration

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 July 22, 2014