NCT00282763

Brief Summary

The purpose of this Study is to test the Safety and Effectiveness of MK0686 in relieving neuropathic (chronic) pain as experienced by patients with Postherpetic Neuralgia (Also Know as PHN or Post Shingles Pain). This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 23, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

January 24, 2006

Last Update Submit

November 20, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • proprietary information - exploratory (non-confirmatory) trial

Secondary Outcomes (1)

  • proprietary information - exploratory (non-confirmatory) trial

Interventions

MK0686DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of postherpetic neuralgia with pain having lasted at least 6 months
  • Able to complete study questionnaires, patient diary, and comply with daily study medication
  • Patient is not satisfied with current treatment for pain control

You may not qualify if:

  • Pregnant or nursing female
  • History of evidence of a condition that in the opinion of the investigator, may interfere with the study results (e.g., diabetic neuropathy of 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

methyl 3-chloro-3'-fluoro-4'-(1-(((1-((trifluoroacetyl)amino)cyclopropyl)carbonyl)amino)ethyl)-1,1'-biphenyl-2-carboxylate

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 27, 2006

Study Start

December 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

November 23, 2015

Record last verified: 2015-11