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NCT01041859 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy
A Phase 3 study of Diabetic Peripheral Neuropathy, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
- 20
- Study locations
NCT01041859: Completed Phase 3 study of Diabetic Peripheral Neuropathy, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT01041859 is a Phase 3 study of Diabetic Peripheral Neuropathy that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 460 participants, above the 101-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (355% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01041859, a Phase 3 study of Diabetic Peripheral Neuropathy, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
For this twice daily pain assessment, the patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tapentadol extended release (ER)
Study Locations (20)
California
- - Fresno
- - Orange
- - Redding
- - Sacramento
- - San Francisco
- - Spring Valley
- - Walnut Creek
Florida
- - Clearwater
- - Hallandale
- - Miami
- - Ormond Beach
- - St. Petersburg
- - Tampa
- - West Palm Beach
Arizona
- - Chandler
- - Mesa
- - Phoenix
Alabama
- - Mobile
Colorado
- - Denver
Georgia
- - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
What the finished NCT01041859 record still lists
NCT01041859 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, above the 101-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (355% higher).
The record links to 1 condition, with Diabetic Peripheral Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01041859 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01041859 about?
NCT01041859 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy". 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) ...
What is the current status of trial NCT01041859?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2009-12. Estimated completion is 2011-03.
What conditions does trial NCT01041859 study?
This clinical trial studies the following conditions: Diabetic Peripheral Neuropathy.
What interventions are being tested in trial NCT01041859?
The interventions under investigation include: Placebo (DRUG), Tapentadol extended release (ER) (DRUG).
Who is sponsoring clinical trial NCT01041859?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01041859 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Peripheral Neuropathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01041859's enrollment target sits among peer trials
460 1st of 17 higher than 17 of 17 other Diabetic Peripheral Neuropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Peripheral Neuropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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