Neuropathic Pain Syndrome Patient Study (MK-0000-072)

April 20, 2015 updated by: Merck Sharp & Dohme LLC

A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug

The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has moderate to severe nerve pain due to one of the following conditions: Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy
  • Patient is able to complete questionnaires in either English or Spanish
  • Patient is at least 18 years of age

Exclusion Criteria:

  • Patient is either pregnant or breastfeeding
  • Patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling)
  • Patient has a history of congestive heart failure
  • Patient has a seizure disorder
  • Patient has a history of drug and/or alcohol abuse within the past 1 year
  • Patient failed treatment due to lack of pain relief with more than three drugs for nerve pain
  • Patient has had cancer (except basal cell carcinoma) within the past two years
  • Patient anticipates the need for surgery while participating in the study
  • Patient has a reported history of hepatitis B, C, or HIV infection
  • Patient has another type of pain that is more painful than the nerve pain
  • Patient has generalized anxiety disorder, untreated depression, psychosis, or post-traumatic stress disorder
  • Patient is involved in litigation or receives worker's compensation related to nerve pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period.
Drug: Comparator: pregabalin
pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
PLACEBO_COMPARATOR: B
Patients in Group B will be treated with placebo.
Drug: Comparator: Placebo (unspecified)
pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Evening Patient Reported Pain Intensity Scores
Time Frame: Baseline and 6 Weeks
Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)
Baseline and 6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study
Time Frame: 6 Weeks
Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (ESTIMATE)

December 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-072
  • 2007_650

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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