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)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00679146
First received: May 6, 2008
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Low Back Pain
Drug: Thiocolchicoside+Ketoprofen
Drug: Thiocolchicoside
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Average pain within the last 24 hours (VAS) [ Time Frame: at D3 visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average pain within the last 24 hours (VAS) [ Time Frame: at D7 visit ] [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: April 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679146

Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Colombia
Sanofi-Aventis Administrative Office
Bogota, Colombia
Egypt
Sanofi-Aventis Administrative Office
Cairo, Egypt
Guatemala
Sanofi-Aventis Administrative Office
Guatemala City, Guatemala
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Venezuela
Sanofi-Aventis Administrative Office
Caracas, Venezuela
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Margarita MURRIETA-AGUTTES Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00679146     History of Changes
Other Study ID Numbers: KETOP_R_02693
Study First Received: May 6, 2008
Last Updated: June 10, 2010
Health Authority: Brazil: Ministry of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Egypt: Ministry of Health and Population
Mexico: Ministry of Health
Venezuela : Ministry of Health

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Colchicine
Ketoprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimitotic Agents
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014