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

CompletedPhase 1NCT00570310
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 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
Conditions
  • Neuralgia, Postherpetic
  • Diabetic Neuropathy
  • Painful Small-Fiber Neuropathy
  • Idiopathic Distal Sensory Polyneuropathy
Interventions
  • Drug: Comparator: pregabalin
  • Drug: Comparator: Placebo (unspecified)
Sponsor
Merck Sharp & Dohme LLC
Start date
2007-12
Primary completion
2008-09
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00570310