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)
Public ClinicalTrials.gov record NCT01063868. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A One-Year, Randomized, Open-Label, Parallel-Group, Multiple-Dose Long-Term Safety Study With Controlled Adjustment of Dose of Tapentadol Extended-Release (ER) and Oxycodone Controlled-Release (CR) in Subjects With Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
Study identification
- NCT ID
- NCT01063868
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Industry
- Enrollment
- 47 participants
Conditions and interventions
Interventions
- Tapentadol extended release (ER) Drug
- Oxycodone controlled release (CR) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2009
- Primary completion
- Mar 31, 2010
- Completion
- May 31, 2010
- Last update posted
- Mar 3, 2014
2010
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mesa | Arizona | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Fruitland Park | Florida | — | — |
| Not listed | New Port Richey | Florida | — | — |
| Not listed | Oviedo | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Libertyville | Illinois | — | — |
| Not listed | Franklin | Indiana | — | — |
| Not listed | Paducah | Kentucky | — | — |
| Not listed | Wellesley Hills | Massachusetts | — | — |
| Not listed | Albuquerque | New Mexico | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Greenville | North Carolina | — | — |
| Not listed | Hickory | North Carolina | — | — |
| Not listed | Wilmington | North Carolina | — | — |
| Not listed | Winston-Salem | North Carolina | — | — |
| Not listed | Kettering | Ohio | — | — |
| Not listed | Tulsa | Oklahoma | — | — |
| Not listed | Greer | South Carolina | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Odessa | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Virginia Beach | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01063868, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 3, 2014 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01063868 live on ClinicalTrials.gov.