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A Study is to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered Tapentadol ER at Dosages of 100 to 250 mg Twice Daily Compared With Placebo in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropath

2014-07-24 14:10:27 | BioPortfolio

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered tapentadol ER at dosages of 100 to 250 mg twice daily compared with placebo in patients with moderate to severe pain due to chronic, painful diabetic peripheral neuropathy (DPN) who have an initial treatment effect (pain improvement) after a 3-week, open-label titration period.

Description

This is a randomized-withdrawal (only patients that have an initial response to tapentadol are assigned to either tapentadol or placebo), placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of orally administered tapentadol, using the extended release tamper-resistant formulation (TRF), at dosages of 100 to 250 mg twice daily in patients with moderate to severe pain due to chronic, painful DPN. The study consists of 1) an open-label (all people involved know the identity of the intervention) phase, including a 13-day screening period, a 5-day washout period (where patients are to stop taking their pain medication), a 3-day pre-titration pain-intensity evaluation period (where patients will record their pain intensity twice daily in the morning and evening), and a 3-week, open-label titration period (all patients receive tapentadol study drug), 2) a 12-week, double-blind (neither physician nor patient knows the name of the assigned drug) maintenance phase, and 3) a posttreatment phase of approximately 10 to 14 days. The study will evaluate the effectiveness of orally administered tapentadol ER versus placebo in reducing patients' pain intensity. The pain intensity will be assessed by comparing the baseline pain level to the level at week 12 of the maintenance phase. The total duration of study drug treatment for each patient will be approximately 15 weeks. Safety and tolerability will be evaluated by vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECGs), standardized neurologic examinations and monitoring of adverse events. Titrate tapentadol extended release (ER) 50mg twice daily to patient's optimal dose ranging between 100 mg ad 250 mg twice a day; placebo (no active ingredients). All doses of study medication will be taken orally with approximately 120mL of water with or without food for a maximum timeframe of 15 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Diabetic Neuropathy, Painful

Intervention

tapentadol extended release (ER), placebo

Location

Mobile
Alabama
United States

Status

Recruiting

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:27-0400

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