RECRUITING

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

Conditions

Morning Sickness Nausea Vomiting Pregnancy Adolescent

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-01

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05289557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Frederic Morneau

CONTACT

450 433-7734/1 877 833-7734

fmorneau@duchesnay.com

Principal Investigator

Rafik Marouf, MD, PhD

STUDY_DIRECTOR

Duchesnay Inc.

Study Locations (Sites)

Velvet Clinical Research

Burbank, California, 91506

United States

Vital Pharma Research

Hialeah, Florida, 33016

United States

New Horizon Research Center

Miami, Florida, 33165

United States

Emerald Coast OB/GYN Clinical Research

Panama City, Florida, 32405

United States

Clinical Research Prime

Idaho Falls, Idaho, 83404

United States

Unified Women's Clinical Research

Winston-Salem, North Carolina, 27043

United States

Clinovacare Medical Research Center

West Columbia, South Carolina, 29169

United States

Maximos OBGYN

League City, Texas, 77573

United States

Axon Clinical Research

Mesquite, Texas, 75149

United States

Advances in Health

Pearland, Texas, 77584

United States

Collaborators and Investigators

Sponsor: Duchesnay Inc.

Rafik Marouf, MD, PhD, STUDY_DIRECTOR, Duchesnay Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-01

Study Completion Date2027-12

Study Record Updates

Study Start Date2022-05-01

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Nausea
Vomiting
Morning Sickness
Pregnancy
Adolescent

Additional Relevant MeSH Terms

Morning Sickness