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Completed Phase 3 Interventional Results available

A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy

ClinicalTrials.gov ID: NCT01041859

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.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 11:59 AM EDT

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)

Study identification

NCT ID
NCT01041859
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry
Enrollment
460 participants

Conditions and interventions

Interventions

  • Tapentadol extended release (ER) Drug
  • Placebo 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
Nov 30, 2009
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011
Last update posted
Sep 10, 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 10, 2013 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01041859 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →