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Completed

NCT Number: NCT00570310

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: pregabalin

Drug

pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Comparator: Placebo (Unspecified)

Drug

pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Primary outcomes

  1. 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

  1. '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)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 10, 2007
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.