Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain (TIOKET)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Low Back Pain

Treatments

Drug: Thiocolchicoside+Ketoprofen

Drug: Thiocolchicoside

Study type

Interventional

Funder types

Industry

Identifiers

NCT00679146

KETOP_R_02693

Details and patient eligibility

About

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

Enrollment

334 patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

List of Inclusion and Exclusion criteria :

Inclusion Criteria:

Non specific low back pain with an acute episode of recent onset (<48 hours) defined by average pain within the last 24 hours equal or more than 50 mm on the Visual Analogue Scale (VAS)
Low back pain of diagnosis category 1 (low back pain radiating no farther than the intergluteal fold) or 2 (low back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain

Exclusion Criteria:

Exclusion criteria related to study methodology:

Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders,
Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain
History of inflammatory arthritis of large joints,
History of seizure disorders,
History of malignant tumour,
Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids,
Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission,
Psychiatric or mental diseases,
Immunosuppression, HIV,
Inclusion in another study in the past six months or previous inclusion in this study,
History of alcohol, drugs or narcotics abuse
Recent history of violent trauma,
Constant progressive, non mechanical pain (no relief with bed rest),
Thoracic pain,
Patient systemically unwell,
Unexplained weight loss,
Widespread neurological symptoms (including cauda equine syndrome),
Structural deformity
Fever,
Clinical significant renal dysfunction defined by Creatinine > 1.5 UNL,
Clinically significant hepatic dysfunction defined by:
Total Bilirubin > 2 UNL
SGOT (AST) > 1.5 UNL
SGPT (ALAT) > 1.5 UNL
Alkaline Phosphatase > 1.5 UNL
Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy...) within the last 48 hours.

Exclusion criteria related to trial drugs:

Pregnancy, breast feeding or women of childbearing potential not using efficient contraception. Patient with Intra Uterine Device should use another form of contraception as the efficacy of the IUD may be reduced by ketoprofen.

Exclusion criteria related to thiocolchicoside:

Known or suspected hypersensitivity to thiocolchicoside

Exclusion criteria related to ketoprofen:

Uncontrolled heart failure,
Arterial Hypertension (SBP>140 mmHg or DBP >90 mmHg),
Stroke or myocardial infarction in the past,
Myopathy
Myasthenia,
History of active peptic ulcer or gastrointestinal (GI) bleeding, history of gastric pain with NSAIDs,
History of NSAID/aspirin-induced asthma,
Known or suspected hypersensitivity to ketoprofen.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.