Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum
NCT ID: NCT03785691
Last Updated: 2023-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
58 participants
INTERVENTIONAL
2019-03-01
2022-07-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Bispebjerg Hospital
OTHER
Aarhus University Hospital
OTHER
Herlev and Gentofte Hospital
OTHER
Hvidovre University Hospital
OTHER
Odense University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Regionernes Medicinpulje
UNKNOWN
Kolding Sygehus
OTHER
Nordsjaellands Hospital
OTHER
Responsible Party
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Anne Ostenfeld
MD, PhD student
Principal Investigators
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Anne Ostenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and gynecology, Nordsjællands Hospital Hillerød
Locations
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Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, , Denmark
Department of Gynaecology and Obstetrics, Rigshospitalet
Copenhagen, , Denmark
Department of Gynaecology and Obstetrics, Herlev Hospital
Herlev, , Denmark
Department of Gynaecology and Obstetrics, Nordsjællands Hospital
Hillerød, , Denmark
Department of Gynaecology and Obstetrics, Hvidovre Hospital
Hvidovre, , Denmark
Department of Gynaecology and Obstetrics, Kolding Sygehus
Kolding, , Denmark
Department of Gynaecology and Obstetrics, Odense University Hospital
Odense, , Denmark
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol: Current version
Document Type: Study Protocol: Original version
Document Type: Statistical Analysis Plan: Current version
Document Type: Statistical Analysis Plan: Original version
Other Identifiers
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VOMIT
Identifier Type: -
Identifier Source: org_study_id
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