Trial · NCT02246439
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 | Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population | 24 Hours | Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose |
| Secondary | Responders Through 4 Days After First Dose of Study Medication - ITT Population | 4 Days | Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication. |
| Secondary | Number of Participants Who Vomited - ITT Population | 24 Hours | Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose |
| Secondary | Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population | 24 Hours | Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication. |
| Secondary | Number of Patients Receiving Intravenous Fluids - ITT Population | 24 Hours | Patients receiving parenteral hydration within 24 hours after the first dose of study medication. |
| Secondary | Severity of Nausea at Baseline - ITT Population | Day 1 - Baseline through 5 Hours Post Dose | Severity of nausea was assessed using a 5-point Likert scale: 0=no nausea; 1=mild nausea; 2=moderate nausea; 3=severe nausea; 4=nausea as bad as can be. |
| Secondary | Incidence and Severity of Diarrhea - ITT Population | From 30 Minutes Through 24 Hours after First Dose of Study Medication | Severity of diarrhea for patients having bowel movements was assessed using the Bristol Stool Scale ("BSS"), a Likert scale rating bowel movements from 1=separate hard lumps, like nuts, to 7=watery, no solid pieces; entirely liquid. The BSS was added to the emergency room day and follow-up diaries beginning with protocol amendment 3. |
| 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 | Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate. |
| Secondary | Time to Resumption of Normal Activities (Work/School/Household) - ITT Population | Hours from first dose of study medication to resumption of normal activities | Time from first dose of study medication to resumption of normal activities (work/school/household). |
| Secondary | Number of Patients Requiring Hospitalization - ITT Population | Day 1 of Study - Day 5 of Study | Number of patients requiring hospitalization. 4 patients in the RHB-102 treatment group and 1 patient in the placebo treatment group were hospitalized due to lack of efficacy. The remaining patients hospitalized were admitted for reasons other than gastroenteritis. |
| Secondary | Number of Patients Returning to Emergency Department - ITT Population | Day 1 of Study - Day 5 of Study | Proportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge |
| Other | Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages | 24 Hours | Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose |
| Other | Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population | 24 Hours | Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose |
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/NCT02246439/registered