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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
274
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.
Velvet Clinical Research
Burbank, California, United States
RECRUITINGVital Pharma Research
Hialeah, Florida, United States
RECRUITINGNausea 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.
Time frame: Day 1-Day 15
Severity and occurrences of maternal adverse events
The secondary objective of this study is to compare the safety of Bonjesta with placebo in pregnant adolescents aged 12 to 17 years by assessing differences in the severity and occurrence of AEs.
Time frame: Day 1-Day 15
Overall well-being from Baseline to Day 15
The secondary objective of this study is the change in the Global Assessment of Well-being score (0 being the worst, 10 being the best rating of overall well-being) from baseline (Day 1) to Day 15 between adolescents randomized to Bonjesta and placebo.
Time frame: Day 1-Day 15
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New Horizon Research Center
Miami, Florida, United States
RECRUITINGEmerald Coast OB/GYN Clinical Research
Panama City, Florida, United States
RECRUITINGClinical Research Prime
Idaho Falls, Idaho, United States
RECRUITINGUnified Women's Clinical Research
Winston-Salem, North Carolina, United States
RECRUITINGClinovacare Medical Research Center
West Columbia, South Carolina, United States
RECRUITINGMaximos OBGYN
League City, Texas, United States
RECRUITINGAxon Clinical Research
Mesquite, Texas, United States
RECRUITINGAdvances in Health
Pearland, Texas, United States
RECRUITING