Investigation of the effect of ondansetron and mirtazapine as treatment for severe nausea and vomiting of pregnancy.

Validating the Effect of Ondansetron and Mirtazapine In Treating Hyperemesis Gravidarum. A Double-blind Randomized Placebo-Controlled Multicentre Trial. - VOMIT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002285-39-DK

Enrollment

180

Registered

2018-09-25

Start date

2018-12-03

Completion date

Unknown

Last updated

2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperemesis gravidarum MedDRA version: 20.0 Level: PT Classification code 10020614 Term: Hyperemesis gravidarum System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: Mirtazapin KRKA 15 mg tablet Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Ondansetron Bluefish film

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Pregnant with gestational age between 5+0 and 19+6 • Nausea and vomiting without other obvious reason • PUQE-24 score =13 OR PUQE-24 score =7 AND 1. weight loss >5% of pre-pregnancy weight OR 2. hospitalisation due to nausea and vomiting of pregnancy • Normal singleton pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Mola-, multiple- or non-vital pregnancy • Congenital long QT-syndrome • Ongoing treatment with antidepressant medication • Not able to take medicine orally • Not able to understand spoken and written Danish

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to compare the efficacy of mirtazapine versus placebo on nausea and vomiting in patients with hyperemesis gravidarum. The secondary objective is to compare the efficacy of ondansetron versus placebo and mirtazapine versus ondansetron on nausea and vomiting in patients with hyperemesis gravidarum. ;Secondary Objective: The secondary objective is to compare the efficacy of ondansetron versus placebo and mirtazapine versus ondansetron on nausea and vomiting in patients with hyperemesis gravidarum.;Primary end point(s): The co-primary endpoints are: • change in PUQE-24 score from baseline to day 2 (short term) in the mirtazapine group versus the placebo group. • change in PUQE-24 score from baseline to day 2 (short term) in the ondansetron group versus the placebo group (this will be tested only if mirtazapine versus placebo on day 2 is significant). • change in PUQE-24 score from baseline to day 2 (short term) in the mirtazapine group versus the ondansetron group (this will be tested only if ondansetron versus placebo on day 2 is significant).;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated daily during the intervention.	—

Measure

Time frame

Main Objective: The primary objective is to compare the efficacy of mirtazapine versus placebo on nausea and vomiting in patients with hyperemesis gravidarum. The secondary objective is to compare the efficacy of ondansetron versus placebo and mirtazapine versus ondansetron on nausea and vomiting in patients with hyperemesis gravidarum. ;Secondary Objective: The secondary objective is to compare the efficacy of ondansetron versus placebo and mirtazapine versus ondansetron on nausea and vomiting in patients with hyperemesis gravidarum.;Primary end point(s): The co-primary endpoints are: • change in PUQE-24 score from baseline to day 2 (short term) in the mirtazapine group versus the placebo group. • change in PUQE-24 score from baseline to day 2 (short term) in the ondansetron group versus the placebo group (this will be tested only if mirtazapine versus placebo on day 2 is significant). • change in PUQE-24 score from baseline to day 2 (short term) in the mirtazapine group versus the ondansetron group (this will be tested only if ondansetron versus placebo on day 2 is significant).;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated daily during the intervention.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints include: • change in PUQE-24 score from baseline to day 14(+/-) (long term) in the mirtazapine group versus the placebo group (this will be tested only if mirtazapine versus placebo on day 2 is significant). • change in PUQE-24 score from baseline to day 14(+/-) (long term) in the ondansetron group versus the placebo group (this will be tested only if ondansetron versus placebo on day 2 is significant). • Change in PUQE-24 score on long term in the mirtazapine group versus the ondansetron group. • Area under the curve for PUQE-24 score during the intervention. • PUQE well-being score. • Number of daily vomiting episodes. • Nausea VAS. • Side effects. • NVPQOL (health-related quality of life for nausea and vomiting during pregnancy). • HELP (hyperemesis level prediction). • EQ-5D (health-related quality of life). • Modified PSQI (Pittsburg Sleep Quality Index) • Patient satisfaction with treatment VAS. • Patient consideration of termination of pregnancy. • Request for dosage increase. • Request for continuation of trial medication after end of intervention. • Use of rescue medication. • Days on sick leave. • Amount of treatments with i.v.-fluids. • Days of hospitalisation. • Weight change. • Pregnancy outcome (birth weight, gestational age, APGAR, umbilical cord pH, placenta weight, sex, mode of delivery, delivery complications, hospitalisations on neonatal ward during the first month, congenital malformations, loss/termination of pregnancy). • Occurrence of treatment failure.;Timepoint(s) of evaluation of this end point: Please refer to section E.5.2 for specification of time of evaluation of secondary endpoints.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints include: • change in PUQE-24 score from baseline to day 14(+/-) (long term) in the mirtazapine group versus the placebo group (this will be tested only if mirtazapine versus placebo on day 2 is significant). • change in PUQE-24 score from baseline to day 14(+/-) (long term) in the ondansetron group versus the placebo group (this will be tested only if ondansetron versus placebo on day 2 is significant). • Change in PUQE-24 score on long term in the mirtazapine group versus the ondansetron group. • Area under the curve for PUQE-24 score during the intervention. • PUQE well-being score. • Number of daily vomiting episodes. • Nausea VAS. • Side effects. • NVPQOL (health-related quality of life for nausea and vomiting during pregnancy). • HELP (hyperemesis level prediction). • EQ-5D (health-related quality of life). • Modified PSQI (Pittsburg Sleep Quality Index) • Patient satisfaction with treatment VAS. • Patient consideration of termination of pregnancy. • Request for dosage increase. • Request for continuation of trial medication after end of intervention. • Use of rescue medication. • Days on sick leave. • Amount of treatments with i.v.-fluids. • Days of hospitalisation. • Weight change. • Pregnancy outcome (birth weight, gestational age, APGAR, umbilical cord pH, placenta weight, sex, mode of delivery, delivery complications, hospitalisations on neonatal ward during the first month, congenital malformations, loss/termination of pregnancy). • Occurrence of treatment failure.;Timepoint(s) of evaluation of this end point: Please refer to section E.5.2 for specification of time of evaluation of secondary endpoints.

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Countries

Denmark

Contacts

Public Contactanne.ostenfeld.02@regionh.dk

Department of Gynaecology and Obstetrics Nordsjællands Hospital

anne.ostenfeld.02@regionh.dk+4520779758

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 28, 2026