Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.