Comparator: pregabalin
Drugpregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
NCT Number: NCT00570310
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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Notify Me18 year and older
All sexes
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
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)
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)
Merck Sharp & Dohme LLC
Industry
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
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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.
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