Trial · NCT02246439
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population | 24 Hours | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Responders Through 4 Days After First Dose of Study Medication - ITT Population | 4 Days | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Vomited - ITT Population | 24 Hours | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population | 24 Hours | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Receiving Intravenous Fluids - ITT Population | 24 Hours | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Severity of Nausea at Baseline - ITT Population | Day 1 - Baseline through 5 Hours Post Dose | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. | score on a scale | MEAN |
| SECONDARY | Incidence and Severity of Diarrhea - ITT Population | From 30 Minutes Through 24 Hours after First Dose of Study Medication | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population | Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last | Patients were required to stay in the ED for at least 2 hours (first 172 patients) and subsequently, when post-treatment ECGs were introduced, for 4 hours. Since not all patients had prolonged ED stays, a difference in time until patients were clinically eligible for discharge may have been masked. | Hours | MEDIAN |
| SECONDARY | Time to Resumption of Normal Activities (Work/School/Household) - ITT Population | Hours from first dose of study medication to resumption of normal activities | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. | Hours | MEDIAN |
| SECONDARY | Number of Patients Requiring Hospitalization - ITT Population | Day 1 of Study - Day 5 of Study | The number of treated patients requiring hospitalization was low in this study (14 patients). In the RHB-102 group, 11 patients (5.7%) were hospitalized, including one who returned to the ED for gastrointestinal symptoms 2 days after initial treatment. In the placebo treatment group, 3 patients (2.3%) were hospitalized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Returning to Emergency Department - ITT Population | Day 1 of Study - Day 5 of Study | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages | 24 Hours | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population | 24 Hours | The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of study medication if they vomited within 15 minutes of receiving the first dose, \& did not have a primary diagnosis upon discharge from ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Primary Endpoint Subgroup Analysis - PP Population | 24 Hours | The Per Protocol (PP) Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population (Logistic Regression Adjusted by Baseline Nausea Severity) | 24 Hours | The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. The primary efficacy analysis was conducted using the ITT Population. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population (Logistic Regression Adjusted by Baseline Nausea Severity) | 24 Hours | The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving the first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis. | 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
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