Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nordsjaellands Hospital
• Collaborators: Aalborg Universitetshospital; Aalborg University Hospital; Aarhus University Hospital; Bispebjerg Hospital; Herlev and Gentofte Hospital; Hvidovre University Hospital; Kolding Sygehus; Odense University Hospital; Regionernes Medicinpulje; Rigshospitalet, Denmark
• Treatments: Mianserin; Mirtazapine; Ondansetron

Criteria

Inclusion Criteria:

• Written informed consent obtained before any trial related procedures are performed

• Female age >18 years

• Pregnant woman 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 and/or

2. hospitalisation due to nausea and vomiting of pregnancy

• Singleton pregnancy

• The subject must be willing and able to comply with trial protocol

Exclusion Criteria:

• Mola pregnancy, multiple gestation or non-vital pregnancy

• Nausea and vomiting of other aetiology than NVP

• Allergic to selective 5-HT3-receptor antagonists

• Ongoing treatment with antidepressant medication

• Pre-existing diagnosis of chronic kidney disease, diabetes type 1 or 2, significant cardiac disease (incl. long QT syndrome), epilepsy, HIV. In case of other pre-existing conditions subjects might be excluded based on individual assessment by an MD

• Elevated liver enzymes (ALAT>150 U/l)

• Elevated creatinine (>100 µmol/l)

• ECG showing long QT-syndrome (QTc >460msek)

• Weekly alcohol intake >2 units of alcohol

• Not able to take medicine orally

• Not able to understand spoken and/or written Danish

• Participation in another investigational drug trial within current pregnancy