NCT05289557

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

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (estimated)
• Sponsor: Duchesnay Inc. · Industry
• Sex: Female
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a phase III multicenter study designed to assess the efficacy and the safety of Bonjesta in the treatment of NVP in pregnant adolescents from approximately 14-16 study sites in the United States. After obtaining informed consent on Day 1 (i.e., baseline visit), a medical examination will be conducted to ensure eligibility. Participants will be randomized to receive either Bonjesta or placebo. On Day 1, all participants will take 1 tablet of study drug at bedtime. On Day 2, participants will take 1 tablet of study drug at bedtime. If the Pregnancy-Unique Quantification of Emesis (PUQE) score \> 3, the participant will take another tablet of study drug in the morning of Day 3. Therefore, the minimum dosage will be 1 tablet daily at bedtime, increasing, when indicated (i.e., if PUQE \> 3), to the maximal dosage of 2 tablets per day on Days 3 to 14. Participants will be required to complete a diary daily to assess the severity of their NVP using the validated PUQE scale and to record any adverse events (AEs) experienced; the Global Assessment of Well-being scale will also be completed in the diary only on Days 1, 8 and 15. Participants will receive telephone calls daily to assess whether the current dosing regimen is sufficient at relieving NVP symptoms, to review study procedures, and to address the participants' questions/concerns. Participants will have study visits on Day 1, Day 3 (±1 day) and Day 15 (±1 day) for an end of study visit.

Conditions

• Morning Sickness

Interventions

Type	Name	Description
DRUG	Bonjesta	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.
DRUG	Placebo	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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-03-21
• Last updated: 2026-04-03

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study