Trial · NCT02985671
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Superiority of the fixed association of orfenadrine 35 mg, acetaminophen 325 mg, caffeine 65 mg and diclofenac sodium 50 mg, compared to Voltaren® in the treatment of the acute mechanical postural low back pain. | 72 hours (± 7 hours) after initiation of treatment. | The primary efficacy variable was the absolute variation of pain intensity measured by the EVA - Visual Analogue Scale of 100mm (0mm = no pain and 100mm = maximum pain) in relation to Baseline (V0), defined as EVA72-0 = (EVA72 - EVA0). |
| Secondary | Relief of pain in the treatment of acute postural mechanical low back pain throughout treatment. | 15', 30', 45', 60', 90', 120', 72h (±7h) and 168h (+48h) after the first administration of the drug for which the study participant was randomized. | Absolute variation of pain intensity measured by EVA - Visual Analog Scale of 100mm (0mm = no pain and 100mm = maximum pain) in relation to the basal (V0). |
| Secondary | Intensity of pain in the treatment of acute postural mechanical low back pain throughout treatment. | 24 hours and 48 hours after the first administration of the drug for which the study participant was randomized | pain intensity measured by EVA - Visual Analog Scale of 100mm (0mm = no pain and 100mm = maximum pain) and reported daily in 24 and 48 hours after the first administration of the drug |
| Secondary | Need for rescue medication to control acute pain between treatment groups during the study period. | 07 days | Proportion of participants who needed at least one rescue medication during the study in each treatment group. |
| Secondary | Number of rescue medication tablets used daily by the research participant in each treatment group. | 07 days | Number of rescue medication tablets used daily by the baseline visit participant up to the final study visit in each treatment group as assessed by the research participant's diary. |
| Secondary | Evaluation of the functional incapacity of the research participants. | 07 days | Absolute variation of the total score of the Roland-Morris functional disability questionnaire assessed at visits V1 and VF, in relation to the total baseline score (V0). This questionnaire consists of 24 dichotomous items (0 = No and 1 = Yes) and thus the total score ranges from 0 to 24 points (0 = no complaints and 24 = very serious limitations). |
| Secondary | Evaluation of the quality of life of the research participants. | 07 days | Absolute variation of the score of each SF-36 quality of life questionnaire domain (functional capacity, limitation for physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health) evaluated in the final visit (VF), in relation to the basal score (V0). The result of each domain of this questionnaire ranges from 0 to 100 points (0 = worst state and 100 = best state). |
| Secondary | Evaluation of participant satisfaction with treatment. | 07 days | 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). |
| Secondary | Assess the safety of treatments during the study period. | The first dose of the study drug up to 30 days after the end of treatment. | Incidence of adverse events (AEs) recorded from the first dose of the study drug up to 30 days after the end of treatment, but all adverse events occurring after the signing of the ICF will be collected and reported. |
| Secondary | Assess the safety of treatments during the study period. | Day of V1 and day of VF. | Absolute variation of the vital signs measured in visits V1 and VF in relation to the baseline visit (V0). |
| Secondary | Assess the safety of treatments during the study period. | Day of V1 and day of VF. | Proportion of participants with clinical or physical changes, considered relevant according to the researcher's criteria, at visits V1 and VF in relation to the baseline visit (V0). |
| Secondary | Assess the safety of treatments during the study period. | Day of V0 and day of VF. | Proportion of participants with altered laboratory tests, considered clinically relevant according to the researcher's criteria, at the baseline visit (V0) and at the final visit (VF) of the study. |
| Secondary | Assess the safety of treatments during the study period. | Day of V0. | Proportion of participants with alterations in the ECG exam, considered clinically relevant according to the researcher's criteria, observed in visits V0. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02985671/registered