Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT03508167
Status:
WITHDRAWN
Last Update Posted:
2019-07-08
First Post:
2018-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Ache Laboratorios Farmaceuticos S.A.
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study design will be reformulated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Delfos
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: