Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
1 other identifier
interventional
183
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 low-back-pain
Started Dec 2004
Shorter than P25 for phase_4 low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedJanuary 15, 2010
January 1, 2010
7 months
June 8, 2009
January 14, 2010
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- Severe heart failure.
- Myopathy / myasthenia.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Mumbai, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manish MISTRY
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
December 1, 2004
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
January 15, 2010
Record last verified: 2010-01