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NCT01063868 · ClinicalTrials.gov registry record · Phase 3
A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Terminated
- Registry status
- Phase 3
- Development phase
- 47
- Enrollment target
NCT01063868: Clinical Trial Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT01063868 is a Phase 3 study that was terminated before completion, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 47 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01063868, a Phase 3 study, was terminated before completion, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 47 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure of up to 1 year.
Primary Outcome
The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
Interventions
- DRUG Tapentadol extended release (ER)
- DRUG Oxycodone controlled release (CR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
Why NCT01063868 stopped before completion
NCT01063868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Tapentadol extended release (ER) is the first listed.
NCT01063868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01063868 about?
NCT01063868 is a clinical study titled "A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)". The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure of up to 1 year.
What is the current status of trial NCT01063868?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 47 participants. The study started on 2010-01. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01063868?
The interventions under investigation include: Tapentadol extended release (ER) (DRUG), Oxycodone controlled release (CR) (DRUG).
Who is sponsoring clinical trial NCT01063868?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01063868's enrollment target sits among peer trials
47 1867th of 2000 higher than 133 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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