National, Phase III, Monocentric, Randomized, Double-blind, Controlled, Parallel, to Evaluate the 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. (Delfos)

NCT03508167 Phase 3 WITHDRAWN

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.

Details

Lead sponsor	Ache Laboratorios Farmaceuticos S.A.
Phase	Phase 3
Status	WITHDRAWN
Start date	2020-01
Completion	2020-11

Conditions

• Low Back Pain

Interventions

• Thermal Band
• Dorilax®
• Placebo

Primary outcomes

• Compare the efficacy and security of Dorilax® plus thermal banc and Placebo plus thermal band — 8 hours
  The relief of the pain will be evaluated using a 6 points scale. 0 = no relief; 1 = little relief; 2 = less than half of relief; 3 = more than half of relief; 4 = a lot of relief; 5 = complete relief; The first 2 hours will be evaluated at the center and the other 6 hours the subject will need to provide a diary completed hourly with the pain evaluation.