Overview

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 FarmacĂȘutica 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