NCT03508167

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.

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.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DEVICE	Thermal Band	Thermal Band used 8 hours per day
DRUG	Dorilax®	2 tablets, orally. In case of moderate pain, another 2 tablets could be administered, respecting the interval of 8 hours between the administrations. Maximum dosage per day: 6 tablets.
DRUG	Placebo	2 tablets, orally. In case of moderate pain, another 2 tablets could be administered, respecting the interval of 8 hours between the administrations. Maximum dosage per day: 6 tablets.

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-10-01
• Completion: 2020-11-01
• First posted: 2018-04-25
• Last updated: 2019-07-08