Overview

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

Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
Female
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. The secondary objective of this study is to compare the safety of Bonjesta in pregnant adolescents aged 12 to 17 years with placebo.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Duchesnay Inc.
Collaborator:
Health Decisions
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 cannabisor 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.