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

Exclusion Criteria

• •1. The investigator confirms the participant's nausea and vomiting is of etiology other than NVP.
• •2. The participant has gestational trophoblastic disease or multifetal gestation.
• •3. 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).
• •4. 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.
• •5. The participant is taking a monoamine oxidase inhibitor.
• •6. 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.
• •7. The participant is using drugs that have anticholinergic activity (eg, tricyclic antidepressants).
• •8. The participant is taking multivitamins containing more than 10 mg of vitamin B6 or plans to do so during the study.
• •9. 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).
• •10. The participant is currently drinking any amount of alcohol.
• •11. 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.
• •12. The participant is likely to be unable to comply with study procedures because of inadequate cognitive or language skills.
• •13. 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.
• •14. The participant is currently breastfeeding.