A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy
Public ClinicalTrials.gov record NCT01041859. 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 Randomized-Withdrawal, Placebo-Controlled, Study Evaluating the Efficacy, Safety, and Tolerability of Tapentadol Extended-Release (ER) 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 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.
Study identification
- NCT ID
- NCT01041859
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 460 participants
Conditions and interventions
Conditions
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 2009 (Type not available)
- Primary completion
- Mar 2011 (Actual)
- Completion
- Mar 2011 (Actual)
- Last update posted
- Sep 11, 2013
2009 – 2011
United States locations
- U.S. sites
- 60
- U.S. states
- 23
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mobile | Alabama | — | — |
| Not listed | Chandler | Arizona | — | — |
| Not listed | Mesa | Arizona | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Fresno | California | — | — |
| Not listed | Orange | California | — | — |
| Not listed | Redding | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | San Francisco | California | — | — |
| Not listed | Spring Valley | California | — | — |
| Not listed | Walnut Creek | California | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Clearwater | Florida | — | — |
| Not listed | Hallandale | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Ormond Beach | Florida | — | — |
| Not listed | St. Petersburg | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | West Palm Beach | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Marietta | Georgia | — | — |
| Not listed | Boise | Idaho | — | — |
| Not listed | Eagle | Idaho | — | — |
| Not listed | Meridian | Idaho | — | — |
| Not listed | Avon | Indiana | — | — |
| Not listed | Evansville | Indiana | — | — |
| Not listed | Fishers | Indiana | — | — |
| Not listed | Prairie Village | Kansas | — | — |
| Not listed | Shreveport | Louisiana | — | — |
| Not listed | Owings Mills | Maryland | — | — |
| Not listed | Pasadena | Maryland | — | — |
| Not listed | Rockville | Maryland | — | — |
| Not listed | Brockton | Massachusetts | — | — |
| Not listed | Edina | Minnesota | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Cedarhurst | New York | — | — |
| Not listed | Flushing | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Valley Stream | New York | — | — |
| Not listed | Williamsville | New York | — | — |
| Not listed | Hickory | North Carolina | — | — |
| Not listed | Akron | Ohio | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Medford | Oregon | — | — |
| Not listed | Allentown | Pennsylvania | — | — |
| Not listed | Altoona | Pennsylvania | — | — |
| Not listed | Duncansville | Pennsylvania | — | — |
| Not listed | Anderson | South Carolina | — | — |
| Not listed | Greer | South Carolina | — | — |
| Not listed | Bulverde | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Odessa | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Schertz | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Alexandria | Virginia | — | — |
| Not listed | Norfolk | Virginia | — | — |
| 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01041859, 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 Sep 11, 2013 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01041859 live on ClinicalTrials.gov.