Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Thiocolchicoside

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Mumbai, India
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Manish MISTRY, Sanofi

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): July 1, 2005
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: June 8, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Estimate): January 15, 2010
• Last Update Submitted That Met QC Criteria: January 14, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: L_9826