Evaluating Bonjesta for treating morning sickness in pregnant teens

A Multicenter Trial of the Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents

This study is testing if Bonjesta can help pregnant teens aged 12 to 17 who are dealing with morning sickness feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (estimated)
• Ages: 12 Years to 17 Years
• Sex: Female
• Sponsor: Duchesnay Inc. (Industry-sponsored)
• Locations: 10 sites (Burbank, California and 9 other locations)
• Trial ID: NCT05289557 on ClinicalTrials.gov

What this trial studies

This phase III multicenter trial aims to assess the efficacy and safety of Bonjesta in treating nausea and vomiting of pregnancy (NVP) in adolescents aged 12 to 17 years. Participants will be randomized to receive either Bonjesta or a placebo, with dosages adjusted based on the severity of their symptoms as measured by the Pregnancy-Unique Quantification of Emesis (PUQE) scale. The study will involve daily monitoring through diaries and telephone calls, as well as scheduled visits to evaluate treatment effects and any adverse events. The trial will take place across approximately 14-16 sites in the United States.

Who should consider this trial

Good fit: Ideal candidates are pregnant adolescents aged 12 to 17 years experiencing moderate to severe nausea and vomiting.

Not a fit: Patients who are not pregnant or those with mild symptoms of nausea and vomiting may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for managing morning sickness in pregnant adolescents.

How similar studies have performed: Previous studies have shown positive outcomes with similar interventions for nausea and vomiting in pregnancy, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. 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).
2. 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.
3. 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.
4. The participant is suffering from NVP and has a PUQE score ≥ 6.
5. The participant has not responded to conservative management consisting of dietary/lifestyle advice according to the 2018 ACOG Practice Bulletin.
6. The participant agrees, if on a multivitamin, to continue on her current dose of multivitamin for the duration of the trial.
7. The participant does not plan termination of the pregnancy.
8. The participant is judged to be in good health based on her medical history, physical examination and laboratory tests
9. The participant must be able to swallow the study drug whole (i.e., without splitting, crushing, or chewing the tablets) on an empty stomach.

Exclusion Criteria:

1. The investigator confirms the participant's nausea and vomiting is of etiology other than NVP.
2. The participant has gestational trophoblastic disease or multifetal gestation.
3. 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).
4. 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.
5. The participant is taking a monoamine oxidase inhibitor.
6. 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.
7. The participant is using drugs that have anticholinergic activity (e.g., tricyclic antidepressants).
8. The participant is taking multivitamins containing more than 10 mg of vitamin B6 or plans to do so during the study.
9. 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).
10. 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).
11. The participant is currently drinking any amount of alcohol or taking illicit drugs
12. 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.
13. The participant is likely to be unable to comply with study procedures because of inadequate cognitive or language skills.
14. 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.
15. The participant is currently breastfeeding.

Where this trial is running

Burbank, California and 9 other locations

• Velvet Clinical Research — Burbank, California, United States (Recruiting)
• Vital Pharma Research — Hialeah, Florida, United States (Recruiting)
• New Horizon Research Center — Miami, Florida, United States (Recruiting)
• Emerald Coast OB/GYN Clinical Research — Panama City, Florida, United States (Recruiting)
• Clinical Research Prime — Idaho Falls, Idaho, United States (Recruiting)
• Unified Women's Clinical Research — Winston-Salem, North Carolina, United States (Recruiting)
• Clinovacare Medical Research Center — West Columbia, South Carolina, United States (Recruiting)
• Maximos OBGYN — League City, Texas, United States (Recruiting)
• Axon Clinical Research — Mesquite, Texas, United States (Recruiting)
• Advances in Health — Pearland, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Frederic Morneau

Conditions Morning Sickness; Nausea; Vomiting; Pregnancy; Adolescent