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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: t
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• 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.

• 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.

Locations
United States
California
Velvet Clinical Research
RECRUITING
Burbank
Florida
Vital Pharma Research
RECRUITING
Hialeah
New Horizon Research Center
RECRUITING
Miami
Emerald Coast OB/GYN Clinical Research
RECRUITING
Panama City
Idaho
Clinical Research Prime
RECRUITING
Idaho Falls
North Carolina
Unified Women's Clinical Research
RECRUITING
Winston-salem
South Carolina
Clinovacare Medical Research Center
RECRUITING
West Columbia
Texas
Maximos OBGYN
RECRUITING
League City
Axon Clinical Research
RECRUITING
Mesquite
Advances in Health
RECRUITING
Pearland
Contact Information
Primary
Frederic Morneau
fmorneau@duchesnay.com
450 433-7734/1 877 833-7734
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 274
Treatments
Active_comparator: Bonjesta
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.
Placebo_comparator: Placebo
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.
Related Therapeutic Areas
Sponsors
Collaborators: Premier Research
Leads: Duchesnay Inc.

This content was sourced from clinicaltrials.gov