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Completed Phase 3 Interventional Results available

A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain

ClinicalTrials.gov ID: NCT00361504

Public ClinicalTrials.gov record NCT00361504. 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 Oct 21, 2026, 9:18 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 One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic Pain

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 tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis.

Study identification

NCT ID
NCT00361504
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
1,123 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
Nov 2006 (Type not available)
Primary completion
Jul 2008 (Actual)
Completion
Jul 2008 (Actual)
Last update posted
Apr 29, 2014

2006 – 2008

United States locations

U.S. sites
40
U.S. states
21
U.S. cities
40
Facility City State ZIP Site status
Not listed Mesa Arizona — —
Not listed Tucson Arizona — —
Not listed Anaheim California — —
Not listed Cudahy California — —
Not listed Encinitas California — —
Not listed San Diego California — —
Not listed Westlake Village California — —
Not listed Trumbull Connecticut — —
Not listed Chiefland Florida — —
Not listed Clearwater Florida — —
Not listed Jacksonville Florida — —
Not listed Oldsmar Florida — —
Not listed Atlanta Georgia — —
Not listed Cumming Georgia — —
Not listed Decatur Georgia — —
Not listed Perry Georgia — —
Not listed Suwanee Georgia — —
Not listed Woodstock Georgia — —
Not listed Indianapolis Indiana — —
Not listed Prairie Village Kansas — —
Not listed Topeka Kansas — —
Not listed Paducah Kentucky — —
Not listed Baton Rouge Louisiana — —
Not listed Rockville Maryland — —
Not listed Wellesley Hills Massachusetts — —
Not listed Kalamazoo Michigan — —
Not listed Las Vegas Nevada — —
Not listed Mamaroneck New York — —
Not listed Williamsville New York — —
Not listed Raleigh North Carolina — —
Not listed Winston-Salem North Carolina — —
Not listed Kettering Ohio — —
Not listed Medford Oregon — —
Not listed Duncansville Pennsylvania — —
Not listed Philadelphia Pennsylvania — —
Not listed Pittsburgh Pennsylvania — —
Not listed Greenville South Carolina — —
Not listed Houston Texas — —
Not listed San Antonio Texas — —
Not listed Roanoke 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 NCT00361504, 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 Apr 29, 2014 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00361504 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →