Trial · NCT03785691
Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum
NCT03785691, Phase 2, Terminated, Nordsjaellands Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum. Trials, record NCT03785691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03785691
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum
- NCT number
- NCT03785691
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Nordsjaellands Hospital
- Conditions
- Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy
- Interventions
- Mirtazapine, Ondansetron, Placebo
- First posted
- 2018-12-24
- Last updated
- 2023-01-30
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group. | 2 days | Change in Pregnancy Unique Quantification of Emesis 24 score (PUQE-24 score) (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group. PUQE-24 score ranges 3-15 with 3 being better and 15 being worse. |
| Primary | Change in nausea and vomiting from baseline to Day 2 (short term) in the ondansetron group versus the placebo group. | 2 days | Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the ondansetron group versus the placebo group. |
| Primary | Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the mirtazapine group versus the placebo group. | 14 days | Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the mirtazapine group versus the placebo group. Only tested if outcome 1 is significant. |
| Primary | Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the ondansetron group versus the placebo group. | 14 days | Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the ondansetron group versus the placebo group. Only tested if outcome 2 is significant. |
| Primary | Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group. | 2 days | Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group. Only tested if outcome 1 is significant. |
| Secondary | Change in nausea and vomiting from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group. | 14 days | Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group. |
| Secondary | Overall nausea and vomiting during the intervention in the three different groups. | 14 days | Area under the curve for PUQE-24 score (patient reported) during the intervention in the three different groups. |
| Secondary | Change in well-being during the intervention in the three different groups. | 14 days | Change in PUQE well-being score (patient reported) during the intervention in the three different groups. |
| Secondary | Change in nausea during the intervention in the three different groups. | 14 days | Change in daily nausea visual analog scale (VAS) (patient reported) during the intervention in the three different groups. VAS score ranges 0-100 with 0 being better and 100 being worse. Numbers are not visible to subjects. |
| Secondary | Change in vomiting during the intervention in the three different groups. | 14 days | Change in number of daily vomiting episodes (patient reported) during the intervention in the three different groups. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT03785691
GET https://conductscience.org/api/trials/v1/NCT03785691/registered?page=2