Status:
UNKNOWN
A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
Lead Sponsor:
Farmoquimica S.A.
Collaborating Sponsors:
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Conditions:
Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 co...
Detailed Description
Phase IIIb, non-inferiority, multicentric, double-blind study.Population: 160 patients, 80 in each study arm, both gender with mild to moderate lumbago, without irradiation and with muscle contraction...
Eligibility Criteria
Inclusion
- Informed of the nature of the study and given written informed consent
- Patients with mild to moderate lumbago
- Aged between 18 and 65 years old
Exclusion
- Known allergy or sensitivity to drug components
- Treatment with another anti inflammatory or corticoid
- Treatment with oral anticoagulants
- Treatment with oxidase monoamine 2 weeks before the study
- Treatment with methotrexate
- Stomach or duodenal ulcer and gastritis
- Dehydration
- Acute myocardial infarction or heart failure
- Hyperthyroidism
- Pregnant or lactating patients
- Treatment with lithium
- User of alcohol and barbiturates
- Hepatic or renal failure
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01421433
Start Date
May 1 2012
End Date
January 1 2013
Last Update
March 8 2012
Active Locations (1)
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1
Hospital São Luiz
São Paulo, São Paulo, Brazil, 05673-050