CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 460 enrolled
Drug / intervention
Tapentadol extended release (ER) +1 moredrug
Likely dose
Tapentadol extended release (ER) 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01041859
NCT01041859Phase 3Completed
CompareCT.gov

A Randomized-Withdrawal, Placebo-Controlled, Study Evaluating the Efficacy, Safety, and Tolerability of Tapentadol Extended-Release (ER) in Subjects With Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Jan 1, 2010·Updated Sep 11, 2013

In Brief

A Phase 3 clinical trial evaluating Tapentadol extended release (ER) and Placebo for Diabetic Peripheral Neuropathy. Completed, enrolled 460 participants across 72 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered tapentadol extended release (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 tolerated tapentadol (ER) and have an initial treatment effect (pain improvement) after a 3-week, open-label titration period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathy
CountriesCanada, Puerto Rico, United States
CollaboratorsGrünenthal GmbH

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 1, 2010
Enrollment StartDec 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.5 years ago

Interventions

Tapentadol extended release (ER)drug

Type= range, unit= mg, number= 100 to 250, form= tablet, route= oral use. Tapentadol ER optimal dose ranging between 100 mg and 250 mg twice daily for 15 weeks.

Placebodrug

Form= tablet, route= oral use. Matching placebo twice daily.