NCT00917436CompletedPhase 4
Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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