Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum (VOMIT)

Nordsjaellands Hospital

Status and phase: Terminated; Phase 2

Conditions: Nausea Gravidarum; Hyperemesis Gravidarum; Vomiting of Pregnancy

Treatments: Drug: Ondansetron; Drug: Placebo; Drug: Mirtazapine

Study type: Interventional

Funder types: Other

Identifiers

NCT03785691

VOMIT

Details and patient eligibility

About

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).

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 3 patient groups, including a placebo group

Mirtazapine

Experimental group

Description:

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.

Treatment:

Drug: Mirtazapine

Ondansetron

Experimental group

Description:

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.

Treatment:

Drug: Ondansetron

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo