Trial · NCT02246439
BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
NCT02246439, Phase 3, Completed, RedHill Biopharma Limited; results first posted 2019-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis. Trials, record NCT02246439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02246439
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
- NCT number
- NCT02246439
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 330 participants, actual
- Lead sponsor
- RedHill Biopharma Limited
- Conditions
- Gastroenteritis, Gastritis
- Interventions
- RHB-102, Placebo Oral Tablet
- First posted
- 2014-09-22
- Last updated
- 2019-02-20
- Results first posted
- 2019-02-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population | RHB-102 | All ages | 126 | Participants | |
| Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population | Placebo Oral Tablet | All ages | 70 | Participants | |
| Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population | RHB-102 | <18 years of age | 12 | Participants | |
| Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population | Placebo Oral Tablet | <18 years of age | 5 | Participants | |
| Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population | RHB-102 | 18 years of age or older | 114 | Participants | |
| Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population | Placebo Oral Tablet | 18 years of age or older | 65 | Participants | |
| Responders Through 4 Days After First Dose of Study Medication - ITT Population | RHB-102 | 114 | Participants | ||
| Responders Through 4 Days After First Dose of Study Medication - ITT Population | Placebo Oral Tablet | 67 | Participants | ||
| Number of Participants Who Vomited - ITT Population | RHB-102 | Yes | 38 | Participants | |
| Number of Participants Who Vomited - ITT Population | Placebo Oral Tablet | Yes | 33 | Participants |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RHB-102 | 192 | |
| Overall Study | STARTED | Placebo | 129 | |
| Overall Study | Randomized | RHB-102 | 198 | |
| Overall Study | Randomized | Placebo | 132 | |
| Overall Study | COMPLETED | RHB-102 | 180 | |
| Overall Study | COMPLETED | Placebo | 118 | |
| Overall Study | NOT COMPLETED | RHB-102 | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Distension | Gastrointestinal disorders | RHB-102 | 3 | 193 | |
| other | Abdominal Distension | Gastrointestinal disorders | Placebo | 1 | 128 | |
| other | Abdominal Pain | Gastrointestinal disorders | RHB-102 | 3 | 193 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 1 | 128 | |
| other | Constipation | Gastrointestinal disorders | RHB-102 | 9 | 193 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 128 | |
| other | Chest Pain | General disorders | RHB-102 | 2 | 193 | |
| other | Chest Pain | General disorders | Placebo | 2 | 128 | |
| other | Pyrexia | General disorders | RHB-102 | 3 | 193 | |
| other | Pyrexia | General disorders | Placebo | 5 | 128 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RHB-102 | 0 | 193 |
| Total, all-cause mortality | Placebo | 0 | 128 |
| Total, other adverse events | RHB-102 | 44 | 193 |
| Total, other adverse events | Placebo | 19 | 128 |
| Total, serious adverse events | RHB-102 | 5 | 193 |
| Total, serious adverse events | Placebo | 2 | 128 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31702802 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| RHB-102 vs Placebo Oral Tablet: Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population | Trial comparisons |
| RHB-102 vs Placebo Oral Tablet: Responders Through 4 Days After First Dose of Study Medication - ITT Population | Trial comparisons |
| RHB-102 vs Placebo Oral Tablet: Number of Patients Requiring Hospitalization - ITT Population | Trial comparisons |
| RHB-102 vs Placebo Oral Tablet: Number of Patients Receiving Intravenous Fluids - ITT Population | Trial comparisons |
| RHB-102 vs Placebo Oral Tablet: Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population (Logistic Regression Adjusted by Baseline Nausea Severity) | Trial comparisons |
| RHB-102 vs Placebo Oral Tablet: Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population (Logistic Regression Adjusted by Baseline Nausea Severity) | Trial comparisons |
| RHB-102 vs Placebo Oral Tablet: Number of Patients Returning to Emergency Department - ITT Population | Trial comparisons |
| RHB-102 vs Placebo: deaths from any cause | Trial comparisons |
| RHB-102 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02246439/results?page=2