NCT00364533 is a Phase 3 clinical trial of Tapentadol IR (CG5503) in Arthroplasty, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Who is sponsoring NCT00364533?

NCT00364533 is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

What drugs are being tested in NCT00364533?

Interventions in NCT00364533: Tapentadol IR (CG5503), Placebo, Oxycodone HCL IR, Tapentadol IR (CG5503).

What condition does NCT00364533 study?

NCT00364533 studies Arthroplasty.

Is NCT00364533 still recruiting?

NCT00364533 is currently terminated. Last updated 3 April 2014.

Are results published for NCT00364533?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-04-03 · How we verify

NCT00364533

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension

Terminated Phase 3 Results posted Last updated 3 April 2014

What this trial tests

Phase 3 trial testing Tapentadol IR (CG5503) in Arthroplasty in 367 participants. Terminated before completion.

Timeline

1 October 2006

Primary endpoint
1 December 2007

1 December 2007

Quick facts

Lead sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	367
Start date	1 October 2006
Primary completion	1 December 2007
Estimated completion	1 December 2007
Sites	77 locations across United States, Belgium, Canada, Finland, New Zealand, Spain, Sweden, United Kingdom

Drugs / interventions tested

Tapentadol IR (CG5503) — full drug profile →
Placebo
Oxycodone HCL IR
Tapentadol IR (CG5503) — full drug profile →

Conditions studied

Arthroplasty — all drugs for Arthroplasty →

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. — full company profile →

Who can join

Adults 18 to 80, any sex, with Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sum of Pain Intensity Difference Over 48 Hours (SPID48)
Time frame: 48 hours
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.

Sponsor's own description

The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Arthroplasty

Currently open trials in the same condition.

NCT07425457 — Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial) · NA · recruiting
NCT06323980 — INHANCE Stemless Reverse Shoulder IDE · NA · recruiting
NCT04848896 — Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedur · NA · recruiting
NCT04849884 — To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System. · NA · active not recruiting
NCT05190666 — Healthy Living After Knee Replacement · NA · active not recruiting

Other Johnson & Johnson Pharmaceutical Research & Development, L.L.C. trials

Trials by the same sponsor.

NCT04330248 — A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants · Phase 1 · completed
NCT01094262 — A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthrit · Phase 2 · terminated
NCT01060254 — A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain · Phase 2 · terminated
NCT00973141 — A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis · Phase 2 · terminated
NCT01756404 — Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00364533 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last refreshed: 3 April 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00364533.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing