NCT01587508

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

A Phase III, Randomized, Single-Blind, Superiority Study Comparing The Efficacy And Tolerability Of A New Drug Containing The Combination Meloxicam And Cyclobenzaprine And The Same Components Alone In The Treatment Of Acute Lumbago

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To assess the efficacy and tolerability of a new drug containing the combination meloxicam and cyclobenzaprine in the treatment of acute lumbago, compared to the same components alone. Some eligibility criteria: Have a normal X-ray of the lumbar spine for the age; Have a baseline score in the VAS higher than or equal to 40 mm

Conditions

• Acute Lumbago

Interventions

Type	Name	Description
DRUG	meloxicam/cyclobenzaprine hydrochloride	two oral capsules a day during approximately 07 days
DRUG	meloxicam - Movatec®	two oral tablet a day during approximately 07 days
DRUG	cyclobenzaprine - Miosan®	two oral tablet a day during approximately 07 days

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-04-30
• Last updated: 2016-05-03

Locations

11 sites across 1 country: Brazil