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NCT00361504 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 3
Development phase
1,123
Enrollment target

NCT00361504 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 1,123 participants.

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The verdict

NCT00361504, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 3
Development phase
1,123 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Oxycodone CR
  • DRUG Tapentadol (CG5503) ER

Trial Details

FieldValue
Enrollment Target 1,123 participants
Start Date 2006-11
Est. Completion 2008-07
Phase Phase 3

What the Registry Record Tells You About NCT00361504

The ClinicalTrials.gov registry entry for NCT00361504 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Oxycodone CR is the first listed.

NCT00361504 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00361504 about?

NCT00361504 is a clinical study titled "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". 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.

What is the current status of trial NCT00361504?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,123 participants. The study started on 2006-11. Estimated completion is 2008-07.

What interventions are being tested in trial NCT00361504?

The interventions under investigation include: Oxycodone CR (DRUG), Tapentadol (CG5503) ER (DRUG).

Who is sponsoring clinical trial NCT00361504?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.