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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.

NCT03508167 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-07-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-10-31
Completion
2020-11-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508167 on ClinicalTrials.gov