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

NCT05289557 | Recruiting Phase 3 FDA Drug

• 1 other identifier: Bonjesta-PED-301
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Morning Sickness

Keywords

Nausea; Vomiting; Morning Sickness; Pregnancy; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1-Day 15

Secondary Outcomes (2)

• Severity and occurrences of maternal adverse events

  Day 1-Day 15

• Overall well-being from Baseline to Day 15

  Day 1-Day 15

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Bonjesta DRUG

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.

Bonjesta

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Duchesnay Inc.: lead
• Premier Research: collaborator

Study Sites (10)

Velvet Clinical Research

Burbank, California, 91506, United States

RECRUITING

Vital Pharma Research

Hialeah, Florida, 33016, United States

RECRUITING

New Horizon Research Center

Miami, Florida, 33165, United States

RECRUITING

Emerald Coast OB/GYN Clinical Research

Panama City, Florida, 32405, United States

RECRUITING

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

RECRUITING

Unified Women's Clinical Research

Winston-Salem, North Carolina, 27043, United States

RECRUITING

Clinovacare Medical Research Center

West Columbia, South Carolina, 29169, United States

RECRUITING

Maximos OBGYN

League City, Texas, 77573, United States

RECRUITING

Axon Clinical Research

Mesquite, Texas, 75149, United States

RECRUITING

Advances in Health

Pearland, Texas, 77584, United States

RECRUITING

MeSH Terms

Conditions

Morning Sickness; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rafik Marouf, MD, PhD

  Duchesnay Inc.

  STUDY DIRECTOR

Central Study Contacts

Frederic Morneau

CONTACT

450 433-7734/1 877 833-7734; fmorneau@duchesnay.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

US (10)