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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01063868
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 47 participants
Conditions and interventions
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
- Jan 2010 (Type not available)
- Primary completion
- Apr 2010 (Actual)
- Completion
- Jun 2010 (Actual)
- Last update posted
- Mar 4, 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 4, 2014 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01063868 live on ClinicalTrials.gov.