A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal system.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Farmoquimica S.A.
• Collaborator: Pharmagenix Projetos em Medicina Farmacêutica Ltda.
• Treatments: Acetaminophen; Amitriptyline; Anti-Inflammatory Agents, Non-Steroidal; Caffeine; Carisoprodol; Clonixin; Cyclobenzaprine; Diclofenac

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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