NCT00679146 (TIOKET) is a Phase 3 clinical trial of Thiocolchicoside+Ketoprofen in Low Back Pain, sponsored by Sanofi.

Who is sponsoring NCT00679146?

NCT00679146 is sponsored by Sanofi.

What drugs are being tested in NCT00679146?

Interventions in NCT00679146: Thiocolchicoside+Ketoprofen, Thiocolchicoside.

What condition does NCT00679146 study?

NCT00679146 studies Low Back Pain.

Is NCT00679146 still recruiting?

NCT00679146 is currently completed. Last updated 10 June 2010.

Last reviewed 2010-06-10 · How we verify

NCT00679146: TIOKET

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

Efficacy and Safety of a Fixed Combination (Thiocolchicoside 8 mg + Ketoprofen 100 mg ) Compared to Thiocolchicoside 8 mg Administered Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain

Completed Phase 3 Last updated 10 June 2010

What this trial tests

Phase 3 trial testing Thiocolchicoside+Ketoprofen in Low Back Pain in 334 participants. Completed in 1 June 2009.

Timeline

1 April 2008

Primary endpoint
1 June 2009

1 June 2009

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	334
Start date	1 April 2008
Primary completion	1 June 2009
Estimated completion	1 June 2009
Sites	6 locations across Brazil, Colombia, Egypt, Guatemala, Mexico, Venezuela

Drugs / interventions tested

Thiocolchicoside+Ketoprofen — full drug profile →
Thiocolchicoside (THIOCOLCHICOSIDE) — full drug profile →

Conditions studied

Low Back Pain — all drugs for Low Back Pain →

Sponsor

Sanofi — full company profile →

Who can join

Adults 20 to 55, any sex, with Low Back Pain. 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.

Average pain within the last 24 hours (VAS)
Time frame: at D3 visit

Sponsor's own description

Primary Objective : To demonstrate the superiority of the oral fixed - combination of a muscle relaxant, thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC, on average pain within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset Secondary Objective : To compare the safety of the oral combination to that of oral TCC alone

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 Low Back Pain

Currently open trials in the same condition.

NCT07526012 — Comparative Effects Of Post Isometric Relaxation Versus Active Isolated Stretch In Patients With Piriformis Syndrome · NA · recruiting
NCT07535047 — Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain · NA · recruiting
NCT07463729 — Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome · NA · recruiting
NCT07250568 — Office Program Effects on Pain, Posture, Muscle Physiology, Stress, Ergonomics, and Quality of Life in LBP Workers · NA · recruiting
NCT07467070 — Effectiveness of Pilates on Postural Correction, Core Strength and Flexibility in Younger Individuals With Non-specific · NA · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

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 NCT00679146 (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 Sanofi
Last refreshed: 10 June 2010

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/NCT00679146.

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