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Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00245544
First received: October 26, 2005
Last updated: July 30, 2008
Last verified: July 2008
History of Changes
  Purpose

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).


Condition Intervention Phase
Neuralgia, Postherpetic
 Drug: MK0759
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety; Patient Global Impression of Change assessed at the end of each treatment period. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2005
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245544

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00245544     History of Changes
Other Study ID Numbers: 2005_078, MK0759-004
Study First Received: October 26, 2005
Last Updated: July 30, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
 Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013