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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1-day 15

Awards & highlights

Study Summary

This trial compares the effectiveness & safety of Bonjesta vs placebo for treating nausea & vomiting in pregnant teens aged 12-17.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Nausea and Vomiting of Pregnancy Severity from Baseline to Day 15

Secondary outcome measures

Overall well-being from Baseline to Day 15

Severity and occurrences of maternal adverse events

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duchesnay Inc.Lead Sponsor

6 Previous Clinical Trials

2,348 Total Patients Enrolled

2 Trials studying Morning Sickness

1,501 Patients Enrolled for Morning Sickness

Health DecisionsOTHER

30 Previous Clinical Trials

13,623 Total Patients Enrolled

Rafik Marouf, MD, PhDStudy DirectorDuchesnay Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollments currently available for this trial?

"The information on clinicaltrials.gov indicates that patients are currently being sought for this trial, which was initially posted to the website in May of 2022 and modified most recently in September 2023."

Answered by AI

Is this clinical experiment accommodating elderly participants aged eighty or above?

"The age bracket for this trial necessitates that participants are between 12 to 17 years old. Additionally, 19 clinical trials have been designed for minors while 71 studies exist specifically for seniors aged 65 and above."

Answered by AI

Has Bonjesta attained regulatory endorsement from the FDA?

"Bonjesta is believed to be relatively secure, as evidenced by a score of 3. This rating was granted due to the existence of Phase 3 trial results that suggest both safety and efficacy."

Answered by AI

How many sites are involved in executing this trial?

"Currently, this medical trial is operating at 10 different locations, with two based in Florida (Hialeah and Miami) and one located in Panama City. Therefore, it's essential to pick the local clinic that best suits you to limit travel requirements if you take part."

Answered by AI

What is the scope of this research in terms of patient participation?

"Duchesnay Inc. is responsible for the organisation of this trial, and has determined that a total of 274 eligible participants will be needed in order to execute it. The research will take place at Vital Pharma Research in Hialeah, Florida as well as New Horizon Research Center located near Miami, Idaho."

Answered by AI

Is my profile suitable to be admitted into this research program?

"This clinical trial is now accepting 274 adolescent pregnant women who are experiencing morning sickness. In order to qualify, applicants must be based in the US and aged between 12-17 years old at recruitment time (Day 1) and 18 prior to the completion of the study (Day 15). Additionally, they should have a PUQE score greater than 6; their pregnancy ultrasound shows viable singleton gestation with NVP symptoms initiated within 10 weeks from conception date; they haven't responded to conservative management approaches such as dietary/lifestyle advice according to ACOG Practice Bulletin 2018; if taking multivitamin supplements then continue on current dose for duration of trial"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents

2022. "The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05289557.

All > Pregnancy