Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

Low Back Pain Clinical Trial

Official title:

Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917436
• Other study ID #: L_9826
• Status: Completed
• Phase: Phase 4
• First received: June 8, 2009
• Last updated: January 14, 2010
• Start date: December 2004
• Est. completion date: July 2005

Study information

• Verified date: January 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India:Institutional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Thiocolchicoside

Locations

Country	Name	City	State
India	Sanofi-Aventis Administrative Office	Mumbai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Disability Questionnaire (Roland Morris)		During patient visits: day 1, day 3 and day 5 to 10	No
Secondary	Physician rated Clinical Global Impression Scale		During patient visits: day 1, day 3 and day 5 to 10	No