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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2010-06-11

No results posted yet for this study

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

Interventions

DRUG

Thiocolchicoside+Ketoprofen

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

DRUG

Thiocolchicoside

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

Sponsors & Collaborators

Principal Investigators

  • Margarita MURRIETA-AGUTTES · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Brazil
  • Colombia
  • Egypt
  • Guatemala
  • Mexico
  • Venezuela

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00679146 on ClinicalTrials.gov