Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum

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).

Conditions

• Hyperemesis Gravidarum
• Nausea Gravidarum
• Vomiting of Pregnancy

Interventions

DRUG

Mirtazapine

Mirtazapine 15 mg oral tablet (incapsulated in gelatine to provide blinding) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered once daily (morning). On Day 7 dosage increase is optional. If desired, mirtazapine 30 mg oral tablet (incapsulated in gelatine) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered three times daily (morning, noon and late afternoon). In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.

DRUG

Ondansetron

Ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.

DRUG

Placebo

Placebo oral tablet (empty gelatine capsule) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, placebo oral tablet (empty gelatine capsule) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.

Sponsors & Collaborators

• Bispebjerg Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Herlev and Gentofte Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Regionernes Medicinpulje

  collaborator UNKNOWN

• Kolding Sygehus

  collaborator OTHER

• Nordsjaellands Hospital

  lead OTHER

Principal Investigators

• Anne Ostenfeld, MD · Department of Obstetrics and gynecology, Nordsjællands Hospital Hillerød

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2022-07-31

Completion

2022-07-31

Countries

• Denmark

Study Locations