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Clinical Trials/NCT00570310
NCT00570310
Completed
Phase 1

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

Merck Sharp & Dohme LLC0 sites104 target enrollmentStarted: December 2007Last updated:
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ConditionsNeuralgia, PostherpeticDiabetic NeuropathyPainful Small-Fiber NeuropathyIdiopathic Distal Sensory Polyneuropathy
DrugsComparator: pregabalinComparator: Placebo (unspecified)

Overview

Phase
Phase 1
Status
Completed
Enrollment
104
Primary Endpoint
Daily Evening Patient Reported Pain Intensity Scores
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • 'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study(6 Weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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