Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain

NCT00679146 | Completed Phase 3

• 1 other identifier: KETOP_R_02693
• Study Type: interventional
• Target: 334
• Locations: 6 countries
• Sites: 6

Brief Summary

Primary Objective : To demonstrate the superiority of the oral fixed - combination of a muscle relaxant, thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC, on average pain within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset Secondary Objective : To compare the safety of the oral combination to that of oral TCC alone

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Average pain within the last 24 hours (VAS)

  at D3 visit

Secondary Outcomes (1)

• Average pain within the last 24 hours (VAS)

  at D7 visit

Study Arms (2)

1

ACTIVE COMPARATOR

1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d

Drug: Thiocolchicoside+Ketoprofen

2

ACTIVE COMPARATOR

2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d

Drug: Thiocolchicoside

Interventions

Thiocolchicoside+Ketoprofen DRUG

1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d

1

Thiocolchicoside DRUG

2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d

2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Non specific low back pain with an acute episode of recent onset (\<48 hours) defined by average pain within the last 24 hours equal or more than 50 mm on the Visual Analogue Scale (VAS)
• Low back pain of diagnosis category 1 (low back pain radiating no farther than the intergluteal fold) or 2 (low back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain
• Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders,
• Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain
• History of inflammatory arthritis of large joints,
• History of seizure disorders,
• History of malignant tumour,
• Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission,
• Psychiatric or mental diseases,
• Immunosuppression, HIV,
• History of alcohol, drugs or narcotics abuse
• Recent history of violent trauma,
• Constant progressive, non mechanical pain (no relief with bed rest),
• Thoracic pain,
• Patient systemically unwell,

Sponsors & Collaborators

• Sanofi: lead

Study Sites (6)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

Sanofi-Aventis Administrative Office

Bogotá, Colombia

Location

Sanofi-Aventis Administrative Office

Cairo, Egypt

Location

Sanofi-Aventis Administrative Office

Guatemala City, Guatemala

Location

Sanofi-Aventis Administrative Office

Col. Coyoacan, Mexico

Location

Sanofi-Aventis Administrative Office

Caracas, Venezuela

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

thiocolchicoside

Condition Hierarchy (Ancestors)

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

Study Officials

• Margarita MURRIETA-AGUTTES

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 16, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

CO (1); EG (1); ME (1); VE (1); BR (1); GU (1)