drugset / Trial / NCT03785691
Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum
Phase 2
Terminated
58 enrolled
Nordsjaellands Hospital
Aarhus University Hospital · collabBispebjerg Hospital · collabHerlev and Gentofte Hospital · collabHvidovre University Hospital · collabKolding Sygehus · collabOdense University Hospital · collabRegionernes Medicinpulje · collabRigshospitalet, Denmark · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim is to investigate the efficacy of mirtazapine and ondansetron as treatment for hyperemesis gravidarum(HG). The setup is a double-blind multicenter trial where patients suffering from HG will be randomized to treatment with either mirtazapine, ondansetron or placebo (1:1:1).
Timeline
- Start
- 2019-03-01
- Primary completion
- 2022-07-31
- Completion
- 2022-07-31
Publications
- Ostenfeld A, Carlsen SE, Jensen AK, Futtrup TB, Westergaard HB, Pedersen LH, Andersen JT, Petersen TS, Lokkegaard ECL; VOMIT investigation group. Mirtazapine or ondansetron for hyperemesis gravidarum: a randomized placebo-controlled trial. Am J Obstet Gynecol. 2026 Jun;234(6):1700-1729. doi: 10.1016/j.ajog.2025.12.061. Epub 2025 Dec 30.
- Ostenfeld A, Petersen TS, Futtrup TB, Andersen JT, Jensen AK, Westergaard HB, Pedersen LH, Lokkegaard ECL. Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial. BMJ Open. 2020 Mar 24;10(3):e034712. doi: 10.1136/bmjopen-2019-034712.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirtazapine | Other / unclassified | 15 mg | Oral |
| Subject | Mirtazapine | Other / unclassified | 30 mg | Oral |
| Subject | Ondansetron | Other / unclassified | 8 mg | Oral |