Overview

Security and Efficacy of Dorilax® (Fixed Association of Paracetamol 350 mg, Carisoprodol 150 mg and Caffeine 50 mg) Plus Thermal Band Compared to Placebo Plus Thermal Band in the Treatment of Acute Low Back Pain.

Status:
Withdrawn

Trial end date:
2020-11-01

Target enrollment:

Participant gender:

Summary

National clinical trial, phase III, monocentric, randomized, double-blind, controlled, parallel, study of superiority, in which two hundred and thirty four (234) participants of both sexes, aged equal or more than 18 years and equal or less than 54 years, will be randomly allocated in one of two treatment groups. The first group will use Dorilax® plus thermal band and the second group will use thermal band plus placebo. The results will show the efficacy and security of Dorilax® and compare the efficiency of Dorilax® and thermal band.

Phase:

Phase 3

Details

Lead Sponsor:

Ache Laboratorios Farmaceuticos S.A.

Treatments:

Acetaminophen
Caffeine
Carisoprodol