Clinical Trial: RN624 For Pain Of Post-Herpetic Neuralgia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Proof Of Concept Study Of The Analgesic Effects Of RN624 In Adult Patients With Post-Herpeti
Brief Summary: This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: The primary endpoint is the change from Baseline to Week 6 in average daily pain as measured by an 11-point Numeric Rating Scale (NRS) derived from the patient daily diary. [ Time Frame: 6 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety endpoints include adverse events, physical exams and vital signs, neurological exams, cognition testing, clinical laboratory testing and electrocardiograms. [ Time Frame: 16 weeks ]
- The pharmacokinetics of RN624 will be analyzed and Anti-Drug Antibody [ADA]) testing will be done. [ Time Frame: 16 weeks ]
- Secondary endpoints will examine change from Baseline for various domains of pain, and pain interference with function, using the modified Brief Pain Inventory-short form and various definitions of responder status based on the patient daily diary. [ Time Frame: 16 weeks ]
- Incidence of and time to withdrawal due to lack of efficacy; and usage of rescue medication will be examined. [ Time Frame: 16 weeks ]
- Other secondary endpoints will examine change from Baseline in the Patient's Global Assessment of Pain from Post-herpetic Neuralgia (disease activity) score and the Patient's Global Evaluation of Study Medication (treatment response) [ Time Frame: 16 weeks ]
- score. [ Time Frame: 16 weeks ]
Original Secondary Outcome:
- Other secondary endpoints will examine change from Baseline in the Patient�s Global Assessment of Pain from Post-herpetic Neuralgia (disease activity) score and the Patient�s Global Evaluation of Study Medication (treatment response) score. [ Time Frame: 16 weeks ]
- Secondary endpoints will examine change from Baseline for various domains of pain, and pain interference with function, using the modified Brief Pain Inventory-short form and various definitions of responder status based on the patient daily diary. [ Time Frame: 16 weeks ]
- Incidence of and time to withdrawal due to lack of efficacy; and usage of rescue medication will be examined. [ Time Frame: 16 weeks ]
- Safety endpoints include adverse events, physical exams and vital signs, neurological exams, cognition testing, clinical laboratory testing and electrocardiograms. [ Time Frame: 16 weeks ]
- The pharmacokinetics of RN624 will be analyzed and Anti-Drug Antibody [ADA]) testing will be done. [ Time Frame: 16 weeks ]
Information By: Pfizer
Dates:
Date Received: December 3, 2007
Date Started: November 2007
Date Completion:
Last Updated: October 21, 2009
Last Verified: October 2009