Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

Phase 4

Completed

• Conditions: Low Back Pain

• Registration Number: NCT00917436
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score evaluated by patient-rated visual analog scale: the levels of spontaneous pain is indicated by the patient by means of a 10 centimetre non-graduated scale, in which the patient could estimate the intensity of pain	During patient visits: day 1, day 3 and day 5 to 10

Secondary Outcome Measures

Name	Time	Method
Mobility Hand-to-floor distance is evaluated by a simple graduated bar (0 value at floor).	During patient visits: day 1, day 3 and day 5 to 10
Disability Questionnaire (Roland Morris)	During patient visits: day 1, day 3 and day 5 to 10
Physician rated Clinical Global Impression Scale	During patient visits: day 1, day 3 and day 5 to 10

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇮🇳 Mumbai, India