Trial · NCT04018612
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24) Based on the 11 Point Numeric Pain Rating Scale | Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Sum of Pain Relief From 0 to 24 Hours (TOTPAR24) Based on a 5-point Likert Scale. | Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | MEAN |
| SECONDARY | Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | 0 to 24 Hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | hours | MEDIAN |
| SECONDARY | Time to Meaningful Perceptible Relief (MPR) Measure Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | 0 to 24 Hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | hours | MEDIAN |
| SECONDARY | Patient Global Evaluation of the Study Medication | 0 to 24 Hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration | Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 hours (± 10 min) | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | MEAN |
| SECONDARY | Pain Intensity Rating at Different Timepoints After Dose 1 Administration | 0 to 24 hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | MEAN |
| SECONDARY | Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration | 0 to 24 hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | MEAN |
| SECONDARY | Time to Treatment Failure | 0 to 24 Hours | The Evaluable Population included all randomized participant who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | hours | MEDIAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to 24 Hours in Vital Signs (Systolic Blood Pressure) | 0 to 24 hours | The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries. | mm Hg | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to 24 Hours in Vital Signs (Diastolic Blood Pressure) | 0 to 24 hours | The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries. | mm Hg | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to 24 Hours in Vital Signs (Temperature) | 0 to 24 hours | The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries. | degrees Celsius | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to 24 Hours in Vital Signs (Pulse Rate) | 0 to 24 hours | The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries. | beats/minute | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to 24 Hours in Vital Signs (Respiratory Rate) | 0 to 24 hours | The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries. | breaths/minute | MEAN |
| OTHER_PRE_SPECIFIED | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours After Dosing (AUC 0-24h) | Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose | The PK Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1 resulting in an adequate number of quantifiable concentrations to calculate PK parameters. | microgram*hour/milliliter | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) | Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose | The PK Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1 resulting in an adequate number of quantifiable concentrations to calculate PK parameters | hour*nanogram per milliliter | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Half-life | Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose | The PK Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1 resulting in an adequate number of quantifiable concentrations to calculate PK parameters | hours | MEAN |
| OTHER_PRE_SPECIFIED | Maximum Observed Plasma Concentration (Cmax) | Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose | The PK Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1 resulting in an adequate number of quantifiable concentrations to calculate PK parameters | nanogram per milliliter (ng/ml) | GEOMETRIC_MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT04018612/outcomes