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Completed

NCT Number: NCT00917436

Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

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

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Mumbai, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thiocolchicoside

Drug

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

    Time frame: During patient visits: day 1, day 3 and day 5 to 10

Secondary outcomes

  1. 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

  2. Disability Questionnaire (Roland Morris)

    Time frame: During patient visits: day 1, day 3 and day 5 to 10

  3. Physician rated Clinical Global Impression Scale

    Time frame: During patient visits: day 1, day 3 and day 5 to 10

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 10, 2009
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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