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

Phase 1

Completed

• Conditions: Diabetic Neuropathy; Painful Small-Fiber Neuropathy; Idiopathic Distal Sensory Polyneuropathy; Neuralgia, Postherpetic

• Registration Number: NCT00570310
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2010-01-13
• Results First Submitted QC: 2010-01-13
• Results First Posted: 2010-02-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Daily Evening Patient Reported Pain Intensity Scores	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 Outcome Measures

Name	Time	Method
'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study	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)