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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01063868
The ClinicalTrials.gov registry entry for NCT01063868 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tapentadol extended release (ER) is the first listed.
NCT01063868 reports 0 study locations.
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.
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