Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago

• Status: Withdrawn
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy end tolerability of a new drug containing the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the treatment of acute lumbago.

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

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Amitriptyline; Cyclobenzaprine; Meloxicam

Criteria

Inclusion Criteria:

• Sign, initial and date the Informed Consent Form (ICF);

• Be between 18 and 75 years old;

• Have acute lumbago with onset in less than 72 hours;

• Have a normal X-ray;

• Have a baseline score in the VAS higher than or equal to 40 mm;

Exclusion Criteria:

• Use of triptans;

• Use of monoamine oxidase inhibitors;

• Use of NSAIDs within the last week;

• Previous use of narcotics;

• Have any rheumatologic disease;

• Conditions of chronic pain;

• Have any significant chronic comorbidity;

• Previous history of gastrointestinal bleed or ulcers;

• History of allergy to any of the components of study medications;

• Recent history of a myocardial infarction, cardiac arrhythmia, cardiac conduction block or change, or congestive heart failure;

• Female patients who are pregnant or breastfeeding or who wish to become pregnant or who deny using safe contraceptive methods during the study will not be enrolled in the study;

• Have participated in another clinical trial within the last 12 months.