The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
A Multicenter Trial of the Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
Duchesnay Inc.
274 participants
May 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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.
Exclusion Criteria15
- 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.
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Interventions
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.
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.
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT05289557