Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00917436
First received: June 8, 2009
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Low Back Pain
Drug: Thiocolchicoside
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 [ Time Frame: During patient visits: day 1, day 3 and day 5 to 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mobility Hand-to-floor distance is evaluated by a simple graduated bar (0 value at floor). [ Time Frame: During patient visits: day 1, day 3 and day 5 to 10 ] [ Designated as safety issue: No ]
  • Disability Questionnaire (Roland Morris) [ Time Frame: During patient visits: day 1, day 3 and day 5 to 10 ] [ Designated as safety issue: No ]
  • Physician rated Clinical Global Impression Scale [ Time Frame: During patient visits: day 1, day 3 and day 5 to 10 ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: December 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917436

Locations
India
Sanofi-Aventis Administrative Office
Mumbai, India
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Manish MISTRY Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00917436     History of Changes
Other Study ID Numbers: L_9826
Study First Received: June 8, 2009
Last Updated: January 14, 2010
Health Authority: India:Institutional Ethical Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Colchicine
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014