Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

NCT ID: NCT00917436

Last Updated: 2010-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2005-07-31

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.

Conditions

Low Back Pain

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Thiocolchicoside

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Manish MISTRY

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Mumbai, , India

Countries

India

Other Identifiers

L_9826

Identifier Type: -

Identifier Source: org_study_id