Hyperemesis GravidarumPhase 2VOMITNCT03785691
Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum
A Phase 2 study testing Mirtazapine and Ondansetron in people with Hyperemesis Gravidarum and Nausea Gravidarum, run by Nordsjaellands Hospital at 7 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy
- What is being tested?
- Mirtazapine and Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 7 sitesDenmark
- Study dates
- 1 Mar 2019to 31 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- weight loss >5% of pre-pregnancy weight and/or
Show all 9Show fewer
- hospitalisation due to nausea and vomiting of pregnancy
- Singleton pregnancy
- The subject must be willing and able to comply with trial protocol
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, 8200
Department of Gynaecology and Obstetrics, Rigshospitalet
Copenhagen, 2100
Department of Gynaecology and Obstetrics, Herlev Hospital
Herlev, 2730
Department of Gynaecology and Obstetrics, Nordsjællands Hospital
Hillerød, 3400
Department of Gynaecology and Obstetrics, Hvidovre Hospital
Hvidovre, 2650
Department of Gynaecology and Obstetrics, Kolding Sygehus
Kolding, 6000
Department of Gynaecology and Obstetrics, Odense University Hospital
Odense, 5000
About this study
Official title: Validating the Effect of Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum: A Double-Blind Randomised Placebo-Controlled Multicentre Trial
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).
- Being tested
- Mirtazapine, Ondansetron, Placebo
- Keywords
- Hyperemesis Gravidarum (HG), Mirtazapine, Ondansetron, Pregnancy, Nausea and Vomiting of Pregnancy (NVP), Randomized Controlled Trial (RCT)
- Medical subject headings
- Hyperemesis Gravidarum, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
Also called KRKA Mirtazapine Oral Tablet
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.
OndansetronDrug
Also called Bluefish Ondansetron Oral Tablet
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.
PlaceboDrug
Also called Placebo Oral Tablet
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.
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine | Experimental | 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. Receives: Drug: Mirtazapine |
| Ondansetron | Experimental | 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. Receives: Drug: Ondansetron |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group.
Change in Pregnancy Unique Quantification of Emesis 24 score (PUQE-24 score) (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group. PUQE-24 score ranges 3-15 with 3 being better and 15 being worse.
Measured: 2 days
Change in nausea and vomiting from baseline to Day 2 (short term) in the ondansetron group versus the placebo group.
Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the ondansetron group versus the placebo group.
Measured: 2 days
Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the mirtazapine group versus the placebo group.
Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the mirtazapine group versus the placebo group. Only tested if outcome 1 is significant.
Measured: 14 days
Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the ondansetron group versus the placebo group.
Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the ondansetron group versus the placebo group. Only tested if outcome 2 is significant.
Measured: 14 days
Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group.
Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group. Only tested if outcome 1 is significant.
Measured: 2 days
Secondary outcomes (31)
Change in nausea and vomiting from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group.
Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group.
Measured: 14 days
Overall nausea and vomiting during the intervention in the three different groups.
Area under the curve for PUQE-24 score (patient reported) during the intervention in the three different groups.
Measured: 14 days
Change in well-being during the intervention in the three different groups.
Change in PUQE well-being score (patient reported) during the intervention in the three different groups.
Measured: 14 days
Change in nausea during the intervention in the three different groups.
Change in daily nausea visual analog scale (VAS) (patient reported) during the intervention in the three different groups. VAS score ranges 0-100 with 0 being better and 100 being worse. Numbers are not visible to subjects.
Measured: 14 days
Change in vomiting during the intervention in the three different groups.
Change in number of daily vomiting episodes (patient reported) during the intervention in the three different groups.
Measured: 14 days
Occurrence of side effects in the three different groups.
Occurrence of side effects (patient reported and registered by trial personnel) during and until 5 days after the intervention in the three different groups.
Measured: 19 days
Change in quality of life for nausea and vomiting during pregnancy from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Change in Health-Related Quality of Life for Nausea and Vomiting during Pregnancy (NVPQOL) score (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. NVPQOL score ranges 30-210 with 30 being better and 210 being worse.
Measured: 14 days
Change in severity of hyperemesis gravidarum from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Change in HyperEmesis Level Prediction (HELP) score (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. HELP score ranges 0-50 with 0 being better and 50 being worse.
Measured: 14 days
Change in health-related quality of life from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Change in health status (EQ-5D-5L) (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Measured: 14 days
Change in sleep quality from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Change in modified Pittsburg Sleep Quality Index (PSQI) (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.Modified PSQI score ranges 0-12 with 0 being better and 12 being worse.
Measured: 14 days
Patient satisfaction with treatment Day 7(+/-1) and Day 14(+/-1) in the three different groups.
Patient satisfaction with treatment VAS (patient reported) on Day 7(+/-1) and Day 14(+/-1) in the three different groups. VAS score ranges 0-100 with 0 being better and 100 being worse. Numbers are not visible to subjects.
Measured: 14 days
Change in patient consideration of termination of pregnancy from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Change in patient consideration of termination of pregnancy (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Measured: 14 days
Request for dosage increase in the three different groups.
Frequency of request for dosage increase in the three different groups.
Measured: 14 days
Request for continuation of trial medication after end of intervention in the three different groups.
Frequency of request for continuation of trial medication after end of intervention in the three different groups.
Measured: 14 days
Use of rescue medication during the intervention in the three different groups.
Use of rescue medication during (patient reported) the intervention in the three different groups.
Measured: 14 days
Number of days on sick leave during the intervention in the three different groups
Number of days on sick leave (patient reported) during the intervention in the three different groups
Measured: 14 days
Necessity of i.v.-fluids during the intervention in the three different groups.
Amount of treatments with i.v.-fluids during the intervention in the three different groups.
Measured: 14 days
Need of hospitalisation during the intervention in the three different groups.
Number of days of hospitalisations during the intervention in the three different groups.
Measured: 14 days
Weight change from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Weight change in kg from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Measured: 14 days
Pregnancy outcome: Live birth, loss or termination of pregnancy
Live birth, loss or termination of pregnancy.
Measured: 8 months
Delivery outcome: Mode of delivery
Mode of delivery: Vaginal, cesarian, vacuum extraction.
Measured: 8 months
Delivery outcome: Delivery complications
Eg. postpartum hemorrhage, shoulder dystocia, sphincter rupture
Measured: 8 months
Live birth outcome: birth weight.
Birth weight in g.
Measured: 8 months
Live birth outcome: gestational age at birth.
Gestational age at birth in weeks plus days.
Measured: 8 months
Live birth outcome: APGAR score.
APGAR score at 1, 5 and 10 minutes after birth. APGAR score ranges 0-10 with 0 being worse and 10 being better.
Measured: 8 months
Live birth outcome: umbilical cord pH.
Umbilical cord pH at birth.
Measured: 8 months
Live birth outcome: placenta weight.
placenta weight in g.
Measured: 8 months
Live birth outcome: sex.
offsprings sex.
Measured: 8 months
Live birth outcome: hospitalizations on neonatal ward during the first month post-partum.
Hospitalizations of the offspring in neonatal ward during the first month post-partum.
Measured: 9 months
Live birth outcome: congenital malformations (depending on gestational age also registered on early ended pregnancies).
Congenital malformations.
Measured: 8 months
Occurrence of treatment failure in the three different groups.
Frequency of and time to treatment failure in the three different groups.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Mar 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Why it stopped: Recruiting difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo controlled multicenter trial testing already marketed drugs on a new indication.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Aarhus University Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital, Odense University Hospital, Copenhagen University Hospital, Rigshospitalet, Regionernes Medicinpulje, Kolding Sygehus
- Responsible party
- Principal investigator, Anne Ostenfeld, Nordsjaellands Hospital
- Investigators
- Anne Ostenfeld, MD, Principal investigator, Department of Obstetrics and gynecology, Nordsjællands Hospital Hillerød
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785691
- Sponsor's protocol ID
- VOMIT
- Acronym
- VOMIT
- Status last verified
- Jan 2023
- First submitted
- 13 Nov 2018
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to patient level data and supporting clinical documents may be requested. Requests will be reviewed on the basis of methodological proposal. Patient data will be de-identified to protect the privacy of trial patients in line with applicable laws and regulations.
Publications
Ostenfeld A, Carlsen SE, Jensen AK, Futtrup TB, Westergaard HB, Pedersen LH, Andersen JT, Petersen TS, Lokkegaard ECL; VOMIT investigation group. Mirtazapine or ondansetron for hyperemesis gravidarum: a randomized placebo-controlled trial. Am J Obstet Gynecol. 2026 Jun;234(6):1700-1729. doi: 10.1016/j.ajog.2025.12.061. Epub 2025 Dec 30.
PubMed 41478546Ostenfeld 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.
PubMed 32209630
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Effect of Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum: A Double-Blind Randomised Placebo-Controlled Multicentre Trial
- ClinicalTrials.gov ID
- NCT03785691
- Acronym / sponsor ID
- VOMIT / VOMIT
- Keywords
- Hyperemesis Gravidarum (HG), Mirtazapine, Ondansetron, Pregnancy, Nausea and Vomiting of Pregnancy (NVP), Randomized Controlled Trial (RCT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting difficulties
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Aarhus University Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital, Odense University Hospital, Copenhagen University Hospital, Rigshospitalet, Regionernes Medicinpulje, Kolding Sygehus
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized placebo controlled multicenter trial testing already marketed drugs on a new indication.
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Experimental | Drug: MirtazapineMirtazapine 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 | Experimental | Drug: OndansetronOndansetron 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 comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirtazapineAlso: KRKA Mirtazapine Oral TabletMirtazapine 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 | Mirtazapine |
| OndansetronAlso: Bluefish Ondansetron Oral TabletOndansetron 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 | Ondansetron |
| PlaceboAlso: Placebo Oral TabletPlacebo 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. | Drug | Placebo |
Primary outcome
Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group.
Time frame: 2 days
Change in Pregnancy Unique Quantification of Emesis 24 score (PUQE-24 score) (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group. PUQE-24 score ranges 3-15 with 3 being better and 15 being worse.
Change in nausea and vomiting from baseline to Day 2 (short term) in the ondansetron group versus the placebo group.
Time frame: 2 days
Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the ondansetron group versus the placebo group.
Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the mirtazapine group versus the placebo group.
Time frame: 14 days
Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the mirtazapine group versus the placebo group. Only tested if outcome 1 is significant.
Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the ondansetron group versus the placebo group.
Time frame: 14 days
Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the ondansetron group versus the placebo group. Only tested if outcome 2 is significant.
Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group.
Time frame: 2 days
Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group. Only tested if outcome 1 is significant.
31 secondary outcomes
Change in nausea and vomiting from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group.
Time frame: 14 days
Overall nausea and vomiting during the intervention in the three different groups.
Time frame: 14 days
Change in well-being during the intervention in the three different groups.
Time frame: 14 days
Change in nausea during the intervention in the three different groups.
Time frame: 14 days
Change in vomiting during the intervention in the three different groups.
Time frame: 14 days
Occurrence of side effects in the three different groups.
Time frame: 19 days
Change in quality of life for nausea and vomiting during pregnancy from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Time frame: 14 days
Change in severity of hyperemesis gravidarum from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Time frame: 14 days
Change in health-related quality of life from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Time frame: 14 days
Change in sleep quality from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Time frame: 14 days
Patient satisfaction with treatment Day 7(+/-1) and Day 14(+/-1) in the three different groups.
Time frame: 14 days
Change in patient consideration of termination of pregnancy from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Time frame: 14 days
Request for dosage increase in the three different groups.
Time frame: 14 days
Request for continuation of trial medication after end of intervention in the three different groups.
Time frame: 14 days
Use of rescue medication during the intervention in the three different groups.
Time frame: 14 days
Number of days on sick leave during the intervention in the three different groups
Time frame: 14 days
Necessity of i.v.-fluids during the intervention in the three different groups.
Time frame: 14 days
Need of hospitalisation during the intervention in the three different groups.
Time frame: 14 days
Weight change from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Time frame: 14 days
Pregnancy outcome: Live birth, loss or termination of pregnancy
Time frame: 8 months
Delivery outcome: Mode of delivery
Time frame: 8 months
Delivery outcome: Delivery complications
Time frame: 8 months
Live birth outcome: birth weight.
Time frame: 8 months
Live birth outcome: gestational age at birth.
Time frame: 8 months
Live birth outcome: APGAR score.
Time frame: 8 months
Live birth outcome: umbilical cord pH.
Time frame: 8 months
Live birth outcome: placenta weight.
Time frame: 8 months
Live birth outcome: sex.
Time frame: 8 months
Live birth outcome: hospitalizations on neonatal ward during the first month post-partum.
Time frame: 9 months
Live birth outcome: congenital malformations (depending on gestational age also registered on early ended pregnancies).
Time frame: 8 months
Occurrence of treatment failure in the three different groups.
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Recruiting difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Derived from this study: PubMed 41478546Ostenfeld A, Carlsen SE, Jensen AK, Futtrup TB, Westergaard HB, Pedersen LH, Andersen JT, Petersen TS, Lokkegaard ECL; VOMIT investigation group. Mirtazapine or ondansetron for hyperemesis gravidarum: a randomized placebo-controlled trial. Am J Obstet Gynecol. 2026 Jun;234(6):1700-1729. doi: 10.1016/j.ajog.2025.12.061. Epub 2025 Dec 30.
- Derived from this study: PubMed 32209630Ostenfeld 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.
- Individual participant dataSharing planned: Yes. Access to patient level data and supporting clinical documents may be requested. Requests will be reviewed on the basis of methodological proposal. Patient data will be de-identified to protect the privacy of trial patients in line with applicable laws and regulations.
Related trials for Hyperemesis Gravidarum
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
Not yet recruitingObservational study
Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
Hyperemesis Gravidarum, Nausea and Vomiting of Pregnancy
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruitingEarly Phase 1
Haloperidol For Outpatient Symptom Management in Patients Diagnosed With Cannabinoid Hyperemesis Syndrome in the Emergrency Department
Cannabinoid Hyperemesis Syndrome
RecruitingPhase 1/2
Hyperemesis Gravidarum Risk Reduction With Metformin
Hyperemesis Gravidarum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Ostenfeld, MD principal investigator
Department of Obstetrics and gynecology, Nordsjællands Hospital Hillerød
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirtazapine and Ondansetron in people with Hyperemesis Gravidarum and Nausea Gravidarum, run by Nordsjaellands Hospital at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruiting difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group. (time frame: 2 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785691, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.