NCT01572675 (COXIBUS) is a clinical trial of etorocoxib in Osteoarthritis, sponsored by Organon and Co.

Who is sponsoring NCT01572675?

NCT01572675 is sponsored by Organon and Co.

What drugs are being tested in NCT01572675?

Interventions in NCT01572675: etorocoxib, celecoxib.

What condition does NCT01572675 study?

NCT01572675 studies Osteoarthritis.

Is NCT01572675 still recruiting?

NCT01572675 is currently completed. Last updated 7 February 2022.

Are results published for NCT01572675?

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

Last reviewed 2022-02-07 · How we verify

NCT01572675: COXIBUS

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

Pharmacoepidemiological Study on the Use of Arcoxia® Under Actual Conditions of Use in France

Completed Results posted Last updated 7 February 2022

What this trial tests

trial testing etorocoxib in Osteoarthritis in 547 participants. Completed in 1 March 2015.

Timeline

1 June 2012

Primary endpoint
1 March 2015

1 March 2015

Quick facts

Lead sponsor	Organon and Co
Status	Completed
Study type	OBSERVATIONAL
Enrollment	547
Start date	1 June 2012
Primary completion	1 March 2015
Estimated completion	1 March 2015

Drugs / interventions tested

etorocoxib — full drug profile →
celecoxib (celecoxib) — full drug profile →

Conditions studied

Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Organon and Co — full company profile →

Who can join

Eligibility, any sex, with Osteoarthritis. 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.

Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®
Time frame: Up to 12 months
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose
Reasons for Misuse of Arcoxia® and Celebrex®
Time frame: Up to 12 months
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to
Indications for Which Arcoxia® and Celebrex® Were Prescribed
Time frame: At study entry
The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.
Dosage of Arcoxia® and Celebrex® at Initiation
Time frame: At study entry
Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.
Mean Dosage of Arcoxia® and Celebrex® During Treatment
Time frame: Up to 12 months
The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.
Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
Time frame: Up to 12 months
Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than th

Sponsor's own description

This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical practice in France as well as the use of celecoxib (Celebrex®).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Osteoarthritis

Currently open trials in the same condition.

NCT07404891 — Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis · NA · recruiting
NCT07118501 — A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System · recruiting
NCT06631638 — EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) · NA · recruiting
NCT07198750 — "Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis" · NA · recruiting
NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting

Other Organon and Co trials

Trials by the same sponsor.

NCT05761444 — Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients · Phase 4 · completed
NCT05789576 — A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Regi · Phase 4 · completed
NCT05680740 — A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis · Phase 4 · completed
NCT05560646 — A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 · Phase 2 · completed
NCT05264506 — Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive · Phase 3 · terminated

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 NCT01572675 (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 Organon and Co
Last refreshed: 7 February 2022

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/NCT01572675.

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