Trial · 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.
NCT03508167, Phase 3, Withdrawn, Ache Laboratorios Farmaceuticos S.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT03508167. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03508167
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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.
- NCT number
- NCT03508167
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Conditions
- Low Back Pain
- Interventions
- Thermal Band, Dorilax®, Placebo
- First posted
- 2018-04-25
- Last updated
- 2019-07-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Evaluation of participant satisfaction with treatment | 72 (+24) hours | Satisfaction of the research participant with the treatment, evaluated in the final visit (VF) by means of the visual analog scale of 100 points (EVA of 100mm, being 0mm = totally unsatisfied and 100mm = totally satisfied). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03508167
GET https://conductscience.org/api/trials/v1/NCT03508167/registered