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Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)(0759-004)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00245544
First received: October 26, 2005
Last updated: May 15, 2014
Last verified: May 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: 20
Study Start Date: October 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  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
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: NCT00245544

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00245544     History of Changes
Other Study ID Numbers: 0759-004, MK0759-004, 2005_078
Study First Received: October 26, 2005
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014