Morning SicknessPhase 3NCT05289557
The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
A Phase 3 study testing Bonjesta in people with Morning Sickness, run by Duchesnay Inc. at 10 sites in United States.
Trial summary
The primary objective of this study is to compare the efficacy of Bonjesta for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Morning Sickness
- What is being tested?
- Bonjesta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 May 2022to Dec 2027
- Phase
- Phase 3
- 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 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 following ages: at least 12 years on the day of recruitment (i.e., Day 1) and not yet 18 years on the last day of the study (i.e., Day 15).
- The participant must provide written informed consent and/or assent to participate in the study and agrees that she will follow dosing instructions and complete all required study visits.
- The participant's entry ultrasound indicates a viable singleton pregnancy and confirms gestational age of the fetus is 7-15 weeks + 0 days at the anticipated time of the first dose of study drug provided that her NVP symptoms began ≤ 10 weeks gestation. If an ultrasound was performed within 4 weeks of the study entry visit, and results can be obtained, an additional ultrasound is not necessary.
- The participant is suffering from NVP and has a PUQE score ≥ 6.
- The participant has not responded to conservative management consisting of dietary/lifestyle advice according to the 2018 ACOG Practice Bulletin.
- The participant agrees, if on a multivitamin, to continue on her current dose of multivitamin for the duration of the trial.
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- The participant does not plan termination of the pregnancy.
- The participant is judged to be in good health based on her medical history, physical examination and laboratory tests
- The participant must be able to swallow the study drug whole (i.e., without splitting, crushing, or chewing the tablets) on an empty stomach.
Who cannot join
- The investigator confirms the participant's nausea and vomiting is of etiology other than NVP.
- The participant has gestational trophoblastic disease or multifetal gestation.
- The participant has a condition for which antihistamines, in the opinion of the investigator, are contraindicated (e.g., epilepsy, alcoholism, glaucoma, chronic lung disease, urinary retention, and heart block).
- The participant has a known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the Bonjesta or placebo formulation.
- The participant is taking a monoamine oxidase inhibitor.
- The participant has used antihistamines, anticholinergics, dopamine antagonists, serotonin antagonists, ginger, recreational drugs including cannabis or anti-emetic therapy (including acupressure, acupuncture, homeopathic remedies, medical hypnosis, and relief bands) to treat NVP in the previous 48 hours or plans to do so during the study.
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- The participant is using drugs that have anticholinergic activity (e.g., tricyclic antidepressants).
- The participant is taking multivitamins containing more than 10 mg of vitamin B6 or plans to do so during the study.
- The participant is taking supplementary vitamin B6 in addition to any multivitamin preparation or plans to do so during the study (e.g., total vitamin B6 greater than 10 mg).
- The participant has a medical condition resulting in gastrointestinal malabsorption, such as celiac disease, Crohn's disease, and ulcerative colitis (i.e., may result in low or deficient levels of vitamin B6).
- The participant is currently drinking any amount of alcohol or taking illicit drugs
- The participant has any condition that might interfere with the conduct of the study, in the opinion of the investigator. For example, Bonjesta should be used with caution in females with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction.
- The participant is likely to be unable to comply with study procedures because of inadequate cognitive or language skills.
- The participant has received an investigational drug within 30 days before enrollment in this study or is scheduled to receive an investigational drug during the course of this study.
- The participant is currently breastfeeding.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Velvet Clinical Research
Burbank, California, 91506
Vital Pharma Research
Hialeah, Florida, 33016
Clinical Research Prime
Idaho Falls, Idaho, 83404
Maximos OBGYN
League City, Texas, 77573
Axon Clinical Research
Mesquite, Texas, 75149
New Horizon Research Center
Miami, Florida, 33165
Emerald Coast OB/GYN Clinical Research
Panama City, Florida, 32405
Advances in Health
Pearland, Texas, 77584
Clinovacare Medical Research Center
West Columbia, South Carolina, 29169
Unified Women's Clinical Research
Winston-Salem, North Carolina, 27043
About this study
Official title: A Multicenter Trial of the Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
The primary objective of this study is to compare the efficacy of Bonjesta for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo.
The secondary objective of this study is to compare the safety of Bonjesta in pregnant adolescents aged 12 to 17 years with placebo.
Read the detailed description
This is a phase III multicenter study designed to assess the efficacy and the safety of Bonjesta in the treatment of NVP in pregnant adolescents from approximately 14-16 study sites in the United States.
After obtaining informed consent on Day 1 (i.e., baseline visit), a medical examination will be conducted to ensure eligibility. Participants will be randomized to receive either Bonjesta or placebo.
On Day 1, all participants will take 1 tablet of study drug at bedtime. On Day 2, participants will take 1 tablet of study drug at bedtime. If the Pregnancy-Unique Quantification of Emesis (PUQE) score > 3, the participant will take another tablet of study drug in the morning of Day 3. Therefore, the minimum dosage will be 1 tablet daily at bedtime, increasing, when indicated (i.e., if PUQE > 3), to the maximal dosage of 2 tablets per day on Days 3 to 14. Participants will be required to complete a diary daily to assess the severity of their NVP using the validated PUQE scale and to record any adverse events (AEs) experienced; the Global Assessment of Well-being scale will also be completed in the diary only on Days 1, 8 and 15.
Participants will receive telephone calls daily to assess whether the current dosing regimen is sufficient at relieving NVP symptoms, to review study procedures, and to address the participants' questions/concerns. Participants will have study visits on Day 1, Day 3 (±1 day) and Day 15 (±1 day) for an end of study visit.
- Conditions
- Morning Sickness
- Being tested
- Bonjesta, Placebo
- Keywords
- Nausea, Vomiting, Morning Sickness, Pregnancy, Adolescent
- Medical subject headings
- Morning Sickness, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BonjestaDrug
Extended-release tablets contain 20 mg of doxylamine succinate and 20 mg of pyridoxine hydrochloride. Minimum 1 tablet at bedtime. Up to two pills daily (one tablet in the morning and one tablet at bedtime). The treatment duration is 15 days.
PlaceboDrug
Sugar pills with no active ingredients. Minimum 1 tablet at bedtime. Up to two pills daily (one tablet in the morning and one tablet at bedtime). The treatment duration is 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Bonjesta | Active comparator | 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. Receives: Drug: Bonjesta |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea and Vomiting of Pregnancy Severity from Baseline to Day 15
The primary objective of this study is to compare the efficacy of Bonjesta with placebo for the treatment of NVP in pregnant adolescents aged 12 to 17 years. NVP severity will be compared using the change in Pregnancy-Unique Quantification of Emesis score (PUQE; no symptoms=3; mild=4-6; moderate=7-12; severe=13-15) from baseline (Day 1) to Day 15 between adolescents randomized to Bonjesta and placebo.
Measured: Day 1-Day 15
Secondary outcomes (2)
Severity and occurrences of maternal adverse events
The secondary objective of this study is to compare the safety of Bonjesta with placebo in pregnant adolescents aged 12 to 17 years by assessing differences in the severity and occurrence of AEs.
Measured: Day 1-Day 15
Overall well-being from Baseline to Day 15
The secondary objective of this study is the change in the Global Assessment of Well-being score (0 being the worst, 10 being the best rating of overall well-being) from baseline (Day 1) to Day 15 between adolescents randomized to Bonjesta and placebo.
Measured: Day 1-Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 May 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: The study has been suspended due to the number of patients being so small, rendering the study unfeasible within a reasonable period of time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morning SicknessStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duchesnay Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Rafik Marouf, MD, PhD, Study director, Duchesnay Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289557
- Sponsor's protocol ID
- Bonjesta-PED-301
- Status last verified
- May 2025
- First submitted
- 11 Mar 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial of the Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
- ClinicalTrials.gov ID
- NCT05289557
- Acronym / sponsor ID
- Bonjesta-PED-301
- Conditions
- Morning Sickness
- Keywords
- Nausea, Vomiting, Morning Sickness, Pregnancy, Adolescent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study has been suspended due to the number of patients being so small, rendering the study unfeasible within a reasonable period of time.
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Duchesnay Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 1 May 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Mar 2022 (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 primary objective of this study is to compare the efficacy of Bonjesta for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo.
The secondary objective of this study is to compare the safety of Bonjesta in pregnant adolescents aged 12 to 17 years with placebo.
Detailed description
This is a phase III multicenter study designed to assess the efficacy and the safety of Bonjesta in the treatment of NVP in pregnant adolescents from approximately 14-16 study sites in the United States.
After obtaining informed consent on Day 1 (i.e., baseline visit), a medical examination will be conducted to ensure eligibility. Participants will be randomized to receive either Bonjesta or placebo.
On Day 1, all participants will take 1 tablet of study drug at bedtime. On Day 2, participants will take 1 tablet of study drug at bedtime. If the Pregnancy-Unique Quantification of Emesis (PUQE) score > 3, the participant will take another tablet of study drug in the morning of Day 3. Therefore, the minimum dosage will be 1 tablet daily at bedtime, increasing, when indicated (i.e., if PUQE > 3), to the maximal dosage of 2 tablets per day on Days 3 to 14. Participants will be required to complete a diary daily to assess the severity of their NVP using the validated PUQE scale and to record any adverse events (AEs) experienced; the Global Assessment of Well-being scale will also be completed in the diary only on Days 1, 8 and 15.
Participants will receive telephone calls daily to assess whether the current dosing regimen is sufficient at relieving NVP symptoms, to review study procedures, and to address the participants' questions/concerns. Participants will have study visits on Day 1, Day 3 (±1 day) and Day 15 (±1 day) for an end of study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bonjesta | Active comparator | Drug: BonjestaOn 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. |
| Placebo | Placebo comparator | Drug: PlaceboOn 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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 following ages: at least 12 years on the day of recruitment (i.e., Day 1) and not yet 18 years on the last day of the study (i.e., Day 15).
- The participant must provide written informed consent and/or assent to participate in the study and agrees that she will follow dosing instructions and complete all required study visits.
- The participant's entry ultrasound indicates a viable singleton pregnancy and confirms gestational age of the fetus is 7-15 weeks + 0 days at the anticipated time of the first dose of study drug provided that her NVP symptoms began ≤ 10 weeks gestation. If an ultrasound was performed within 4 weeks of the study entry visit, and results can be obtained, an additional ultrasound is not necessary.
- The participant is suffering from NVP and has a PUQE score ≥ 6.
- The participant has not responded to conservative management consisting of dietary/lifestyle advice according to the 2018 ACOG Practice Bulletin.
Key exclusion criteria (15 listed)
- The investigator confirms the participant's nausea and vomiting is of etiology other than NVP.
- The participant has gestational trophoblastic disease or multifetal gestation.
- The participant has a condition for which antihistamines, in the opinion of the investigator, are contraindicated (e.g., epilepsy, alcoholism, glaucoma, chronic lung disease, urinary retention, and heart block).
- The participant has a known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the Bonjesta or placebo formulation.
- The participant is taking a monoamine oxidase inhibitor.
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 |
|---|---|---|
| BonjestaExtended-release tablets contain 20 mg of doxylamine succinate and 20 mg of pyridoxine hydrochloride. Minimum 1 tablet at bedtime. Up to two pills daily (one tablet in the morning and one tablet at bedtime). The treatment duration is 15 days. | Drug | Bonjesta |
| PlaceboSugar pills with no active ingredients. Minimum 1 tablet at bedtime. Up to two pills daily (one tablet in the morning and one tablet at bedtime). The treatment duration is 15 days. | Drug | Placebo |
Primary outcome
Nausea and Vomiting of Pregnancy Severity from Baseline to Day 15
Time frame: Day 1-Day 15
The primary objective of this study is to compare the efficacy of Bonjesta with placebo for the treatment of NVP in pregnant adolescents aged 12 to 17 years. NVP severity will be compared using the change in Pregnancy-Unique Quantification of Emesis score (PUQE; no symptoms=3; mild=4-6; moderate=7-12; severe=13-15) from baseline (Day 1) to Day 15 between adolescents randomized to Bonjesta and placebo.
2 secondary outcomes
Severity and occurrences of maternal adverse events
Time frame: Day 1-Day 15
Overall well-being from Baseline to Day 15
Time frame: Day 1-Day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
Rafik Marouf, MD, PhD study director
Duchesnay Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bonjesta in people with Morning Sickness, run by Duchesnay Inc. at 10 sites in United States.
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 15 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: paused, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Nausea and Vomiting of Pregnancy Severity from Baseline to Day 15 (time frame: Day 1-Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.