Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00679146 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 320 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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
|
2: Active Comparator
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
|
Ages Eligible for Study: | 20 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
List of Inclusion and Exclusion criteria :
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria related to study methodology:
Exclusion criteria related to trial drugs:
Exclusion criteria related to thiocolchicoside:
Exclusion criteria related to ketoprofen:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact: PUBLIC REGISTRY GMA | publicregistryGMA@sanofi-aventis.com |
Brazil | |
Sanofi-aventis Administrative Office | Recruiting |
Sao Paulo, Brazil | |
Colombia | |
sanofi-aventis Administrative Office | Recruiting |
Bogota, Colombia | |
Egypt | |
sanofi-aventis Administrative Office | Not yet recruiting |
Cairo, Egypt | |
Mexico | |
sanofi-aventis Administrative Office | Recruiting |
Mexico DF, Mexico | |
Venezuela | |
sanofi-aventis Administrative Office | Not yet recruiting |
Caracas, Venezuela |
Study Director: | Margarita MURRIETA-AGUTTES | Sanofi-Aventis |
Responsible Party: | Sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | KETOP_R_02693 |
Study First Received: | May 6, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00679146 |
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 |
Ketoprofen Signs and Symptoms Neurologic Manifestations Low Back Pain |
Colchicine Pain Back Pain |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Nervous System Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Antimitotic Agents Gout Suppressants |
Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Tubulin Modulators Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |