A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents (PED-301)
Morning Sickness
About this trial
This is an interventional treatment trial for Morning Sickness focused on measuring Nausea, Vomiting, Pregnancy, Adolescent, Diclegis, Morning, Sickness
Eligibility Criteria
Inclusion Criteria:
- The participant is a pregnant female between the following ages: at least 12 years on the day of recruitment (ie, Day 1) and not yet 18 years on the last day of the study (ie, 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 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 2004 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.
- On the basis of medical history, physical examination and screening laboratory tests, the participant is judged to be in good health.
- The participant must be able to swallow the study drug whole (ie, without splitting, crushing, or chewing the tablets).
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 (eg, 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 Diclegis or placebo formulation.
- The participant is taking a monoamine oxidase inhibitor.
- The participant has used antihistamines, anticholinergics, dopamine antagonists, serotonin antagonists, ginger, 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 (eg, 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 is currently drinking any amount of alcohol.
- The participant has any condition that might interfere with the conduct of the study, in the opinion of the investigator. For example, Diclegis® 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.
Sites / Locations
- Watching Over Mothers and Babies
- Clinica Del Socorro Medical Group, Inc.
- Futura Research
- Empire Clinical Research, LLC
- Medical Professional CR Center
- Western Michigan University Homer Stryker M.D. School of Medicine
- Jersey Shore University Medical Center
- Complete Healthcare for Women
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Diclegis
Placebo
Participants will be randomized to receive Diclegis or placebo. On Day 1, all participants will take 2 tablets of study drug at bedtime. On Days 2 to 14, participants will take 2 tablets of study drug at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.
Participants will be randomized to receive Diclegis or placebo. On Day 1, all participants will take 2 tablets of study drug at bedtime. On Days 2 to 14, participants will take 2 tablets of study drug at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.