At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 395 enrolled
Drug / intervention
CG5503 +1 moredrug
Likely dose
CG5503 250 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.
A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of CG5503 Extended Release (ER) in Subjects With Painful Diabetic Peripheral Neuropathy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Apr 3, 2007·Updated Jul 19, 2013
In Brief
A Phase 3 clinical trial evaluating CG5503 and placebo for Diabetic Neuropathy. Completed, enrolled 395 participants.
Detailed Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with moderate to severe pain from diabetic peripheral neuropathy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy
Countries--
CollaboratorsGrünenthal GmbH
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedApr 2007
Primary CompletionAug 2008
TodayJul 2026
First PostedApr 3, 2007
Enrollment StartApr 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.2 years ago
Interventions
CG5503drug
100, 150, 200, 250 mg twice daily given for up to 15 weeks
placebodrug
matching placebo twice daily for 12 weeks