NCT00245544TerminatedPhase 2
A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Explore the Safety and Preliminary Efficacy of Oral MK0759 in the Treatment of Postherpetic Neuralgia
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 20
- Primary Endpoint
- Pain intensity recorded by the patient each evening using an 11-point Likert scale (0=no pain to 10=pain as bad as you can imagine).
Study Overview
Brief Summary
The purpose of this study is to test the safety and effect of MK0759 in relieving neuropathic pain as experienced by patients with postherpetic neuralgia (PHN).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 to 85; diagnosis of postherpetic neuralgia with pain having persisted at least 6 months; dissatisfied with current regimen of pain control; able to complete study questionnaires, patient diary, and comply with daily study medication
Exclusion Criteria
- •Women of childbearing potential; history or evidence of a condition that, in the opinion of the investigator, may interfere with the study interpretation (e.g., diabetic neuropathy or fibromyalgia) or pose undue risk to undergo the course of medication required by the study (e.g., unstable heart disease, morbid obesity, kidney or liver disease).
Outcomes
Primary Outcomes
Pain intensity recorded by the patient each evening using an 11-point Likert scale (0=no pain to 10=pain as bad as you can imagine).
Time Frame: Duration of Treatment
Secondary Outcomes
- Safety; Patient Global Impression of Change assessed at the end of each treatment period.(Duration of Treatment)
Investigators
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