Back to resultsThiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Thiocolchicoside
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Outcomes
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
Secondary Outcome Measures
Mobility Hand-to-floor distance is evaluated by a simple graduated bar (0 value at floor).
Disability Questionnaire (Roland Morris)
Physician rated Clinical Global Impression Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00917436
Brief Title
Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
Official Title
Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thiocolchicoside
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Disability Questionnaire (Roland Morris)
Time Frame
During patient visits: day 1, day 3 and day 5 to 10
Title
Physician rated Clinical Global Impression Scale
Time Frame
During patient visits: day 1, day 3 and day 5 to 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish MISTRY
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Mumbai
Country
India
12. IPD Sharing Statement
Learn more about this trial
Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
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