Trial · NCT05102591
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assessment of Recruitment Rate | Evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study) | Number of participants who were screened, deemed eligible, and subsequently enrolled. Three (3) participants during the parallel-group design phase withdrew after consent but before being randomized/receiving study treatments. No other participants withdrew during the study. | participants per month | MEAN |
| SECONDARY | Reduction in Pain Severity | Difference between baseline and 1 hour, 2 hours, and 48 hours post-intervention. | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | units on a scale | MEAN |
| SECONDARY | Number of Eligible Participants Who Are Screened, Enrolled, and Complete All Assessments | Evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study) | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Global Impression of Change | Evaluated for each participant at 2-hours post-intervention, and 48-hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | participants | NUMBER |
| SECONDARY | Study Feedback From Participants and Staff | Participant feedback evaluated at 48 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | units on a scale | MEAN |
| SECONDARY | Number of Participants Reporting Pain Freedom | 2 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Sustained Pain Freedom | 48 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Numbers of Participants Reporting a Change in 4-point Pain Severity Scale Between Baseline and 2 Hours Post-intervention | 2 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Sustained Pain Relief | 48 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Adverse Events | Evaluated from time of intervention to 2 hours and 48 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Freedom From Most Bothersome Symptom | 2 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Discharged From the Emergency Department With no Further Intervention | 2 hours post-intervention (after last intervention, following ED discharge) | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
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/NCT05102591/outcomes