Status:
COMPLETED
Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
Lead Sponsor:
Sanofi
Conditions:
Low Back Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
To assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain.
Eligibility Criteria
Inclusion
- Diagnosis of acute low back pain of recent onset (less than 7 days) and defined by spontaneous pain intensity at rest more than or equal to 50mm of the visual analog scale.
- Presence of lumbar muscular contracture
Exclusion
- Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins
- Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol
- Renal failure (serum creatinine \> 160 µmol/l or \> 1.80 mg/dl) and/or severe hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase and/or total bilirubin \> 2 Upper normal limit).
- Positive history of cerebro-vascular accidents or myocardial infarction in the six months prior the inclusion.
- Severe heart failure.
- Myopathy / myasthenia.
- Patients treated during two days prior to inclusion with steroidal agents.
- Known or suspected hypersensitivity to thiocolchicoside.
- Known or suspected hypersensitivity to nonsteroidal anti-inflammatory drugs
- History of active peptic ulcer or gastro intestinal bleeding.
- History of nonsteroidal anti-inflammatory drugs induced allergic asthma.
- Concomitant treatment with 2-agonists (i.e. clonidine).
- Pregnant or breast feeding women.
- Females of child bearing potential, not taking adequate contraception.
- Patients with history of alcohol, drugs or narcotics abuse.
- Previous inclusion in this study or in another study in the past 6 months.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT00917436
Start Date
December 1 2004
End Date
July 1 2005
Last Update
January 15 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Mumbai, India