Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00917436
• Collaborator: (none)
• Enrollment: 183
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 26.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Drug: Thiocolchicoside	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Primary Purpose: Treatment
• Official Title: Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Jul 1, 2005
• Actual Study Completion Date: Jul 1, 2005

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. Disability Questionnaire (Roland Morris) [During patient visits: day 1, day 3 and day 5 to 10]

3. Physician rated Clinical Global Impression Scale [During patient visits: day 1, day 3 and day 5 to 10]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Mumbai		India

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Manish MISTRY, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00917436
• Other Study ID Numbers: L_9826
• First Posted: Jun 10, 2009
• Last Update Posted: Jan 15, 2010
• Last Verified: Jan 1, 2010

• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Jan 15, 2010