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Neuropathic Pain Syndrome Patient Study

Information source: Merck
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuralgia, Postherpetic; Diabetic Neuropathy; Painful Small-Fiber Neuropathy; Idiopathic Distal Sensory Polyneuropathy

Intervention: Comparator: pregabalin (Drug); Comparator: Placebo (unspecified) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Overall contact:
Toll Free Number, Phone: 1-888-577-8839

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.

Clinical Details

Official 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Daily evening patient reported pain intensity scores

Secondary outcome: 'Time to efficacy failure' during the randomized withdrawal portion of the study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Toll Free Number, Phone: 1-888-577-8839

Call for Information, La Habra, California 90631, United States; Recruiting

Call for Information, Newark, Delaware 19713, United States; Recruiting

Additional Information

Starting date: December 2007
Last updated: October 29, 2008

Page last updated: November 03, 2008

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