What side effects are associated with this type of intervention?

The most common treatments for morning sickness include the combination of doxylamine and pyridoxine, as well as other antihistamines and antiemetics like metoclopramide and ondansetron. Doxylamine, an antihistamine, can cause side effects such as drowsiness, dry mouth, dizziness, and urinary retention due to its anticholinergic properties. Pyridoxine, a form of vitamin B6, is generally well-tolerated but can cause mild side effects like headache, nausea, and sensory neuropathy at high doses. When combined, the doxylamine-pyridoxine treatment is effective but may still present the individual side effects of each component.

What prior FDA approvals exist?

The FDA has approved the combination of doxylamine and pyridoxine for the treatment of morning sickness, which is marketed under the brand name Diclegis. This combination leverages doxylamine, an antihistamine that reduces nausea, and pyridoxine, a form of vitamin B6 that helps alleviate vomiting. Other treatments for nausea and vomiting in pregnancy that have shown benefit include ginger, antihistamines, and metoclopramide. These treatments are often considered based on the severity of symptoms and patient response.

What other types of research exist?

Promising alternatives to Bonjesta for treating morning sickness in 2024 include: 1) Metoclopramide, a prokinetic agent that increases gastric emptying and reduces nausea. 2) Ondansetron, a serotonin 5-HT3 receptor antagonist that is effective in reducing nausea and vomiting. 3) Ginger supplements, which have shown efficacy in reducing nausea in some studies. 4) Acupressure wristbands, which apply pressure to specific points on the wrist to alleviate nausea. These alternatives offer different mechanisms of action and can be considered based on individual patient needs and responses.

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Antiemetic

Bonjesta for Morning Sickness

Phase 3

Recruiting

Research Sponsored by Duchesnay Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The study population will include pregnant adolescents who reside in the US and meet all of the following criteria for inclusion: The participant is a pregnant female between the ages of at least 12 years on the day of recruitment and not yet 18 years on the last day of the study

The participant is suffering from NVP and has a PUQE score ≥ 6

Must not have

The participant has gestational trophoblastic disease or multifetal gestation

The participant is using drugs that have anticholinergic activity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1-day 15

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing Bonjesta, a medication that helps reduce nausea and vomiting, in pregnant adolescents aged 12 to 17 years. Bonjesta combines an antihistamine and vitamin B6 to help manage these symptoms. Bonjesta combines an antihistamine and vitamin B6, which have been used separately in various studies to treat nausea and vomiting in pregnancy.

Who is the study for?

This trial is for pregnant adolescents in the US, aged 12-17 with a viable singleton pregnancy at 7-15 weeks gestation and experiencing morning sickness not improved by diet/lifestyle changes. They must be able to swallow pills whole, agree to follow study procedures, and not plan on ending their pregnancy. Those with certain health conditions or taking conflicting medications cannot participate.

What is being tested?

The trial tests Bonjesta's effectiveness against placebo in treating nausea and vomiting of pregnancy (NVP) among pregnant teenagers. Participants will receive either Bonjesta or a placebo pill to compare how well each works in managing NVP symptoms.

What are the potential side effects?

Bonjesta may cause drowsiness, dry mouth, or dizziness as it contains an antihistamine. It should be used cautiously if the participant has asthma or eye pressure issues due to potential side effects related to these conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a pregnant teenager living in the US, aged 12 to under 18.

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I have severe nausea and vomiting during pregnancy.

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I can swallow pills without chewing, on an empty stomach.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a pregnancy-related tumor or was pregnant with multiples.

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I am currently taking medication that affects my nervous system.

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I am currently taking medication that belongs to the monoamine oxidase inhibitor class.

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I am taking or plan to take multivitamins with over 10 mg of vitamin B6 during the study.

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I have a condition that affects how my body absorbs nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1-day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1-day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1-day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nausea and Vomiting of Pregnancy Severity from Baseline to Day 15

Secondary study objectives

Overall well-being from Baseline to Day 15

Severity and occurrences of maternal adverse events

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: BonjestaActive Control1 Intervention

On Day 1, one tablet will be taken orally at bedtime. If this dose adequately controls symptoms (i.e., PUQE = 3), the participant will be directed to continue taking one tablet daily at bedtime only. However, on Day 2, if symptoms of nausea, retching and/or vomiting persist (i.e., PUQE score \>3), the participant will be directed to take her usual dose of 1 tablet at bedtime and an additional tablet the next morning on Day 3. The minimum dosage prescribed will be 1 tablet daily at bedtime, increasing, when indicated, to the maximal dosage of 2 tablets per day (one tablet in the morning and one tablet at bedtime) starting Day 3 and will continue through Day 14.

Group II: PlaceboPlacebo Group1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for morning sickness include the combination of doxylamine and pyridoxine. Doxylamine is an antihistamine that reduces nausea by blocking histamine receptors, while pyridoxine (vitamin B6) helps alleviate vomiting by supporting neurotransmitter synthesis and function. These mechanisms are crucial for morning sickness patients as they directly target the pathways responsible for nausea and vomiting, offering effective symptom relief.

Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy: A Systematic Review.Comparison of three outpatient regimens in the management of nausea and vomiting in pregnancy.