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)

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Thiocolchicoside+Ketoprofen; Drug: Thiocolchicoside

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office
• Colombia
  • Bogota, Colombia
    • Sanofi-Aventis Administrative Office
• Egypt
  • Cairo, Egypt
    • Sanofi-Aventis Administrative Office
• Guatemala
  • Guatemala City, Guatemala
    • Sanofi-Aventis Administrative Office
• Mexico
  • Col. Coyoacan, Mexico
    • Sanofi-Aventis Administrative Office
• Venezuela
  • Caracas, Venezuela
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d	Drug: Thiocolchicoside+Ketoprofen; 1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d
Active Comparator: 2; 2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d	Drug: Thiocolchicoside; 2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average pain within the last 24 hours (VAS)	at D3 visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Average pain within the last 24 hours (VAS)	at D7 visit

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Margarita MURRIETA-AGUTTES, Sanofi

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: May 6, 2008
• First Submitted That Met QC Criteria: May 15, 2008
• First Posted (Estimate): May 16, 2008

Study Record Updates

• Last Update Posted (Estimate): June 11, 2010
• Last Update Submitted That Met QC Criteria: June 10, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine; Ketoprofen
• Other Study ID Numbers: KETOP_R_02693