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)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Thiocolchicoside+Ketoprofen
Thiocolchicoside
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d
2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d
Outcomes
Primary Outcome Measures
Average pain within the last 24 hours (VAS)
Secondary Outcome Measures
Average pain within the last 24 hours (VAS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00679146
Brief Title
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
Acronym
TIOKET
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d
Arm Title
2
Arm Type
Active Comparator
Arm Description
2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d
Intervention Type
Drug
Intervention Name(s)
Thiocolchicoside+Ketoprofen
Intervention Description
1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d
Intervention Type
Drug
Intervention Name(s)
Thiocolchicoside
Intervention Description
2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d
Primary Outcome Measure Information:
Title
Average pain within the last 24 hours (VAS)
Time Frame
at D3 visit
Secondary Outcome Measure Information:
Title
Average pain within the last 24 hours (VAS)
Time Frame
at D7 visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita MURRIETA-AGUTTES
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis Administrative Office
City
Bogota
Country
Colombia
Facility Name
Sanofi-Aventis Administrative Office
City
Cairo
Country
Egypt
Facility Name
Sanofi-Aventis Administrative Office
City
Guatemala City
Country
Guatemala
Facility Name
Sanofi-Aventis Administrative Office
City
Col. Coyoacan
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Caracas
Country
Venezuela
12. IPD Sharing Statement
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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
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