The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents (NCT05289557) | Clinical Trial Compass
SuspendedPhase 3
The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
Stopped: The study has been suspended due to the number of patients being so small, rendering the study unfeasible within a reasonable period of time.
United States274 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range12 Years – 17 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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).
✓. 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.
What they're measuring
1
Nausea and Vomiting of Pregnancy Severity from Baseline to Day 15
✓. The participant is judged to be in good health based on her medical history, physical examination and laboratory tests
Exclusion criteria
✕. 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.