The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
Condition: Nausea and Vomiting of Pregnancy
MeSH terms: Pregnancy Complications; Nausea; Vomiting
Intervention: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg; Placebo
Intervention description: up to 4 tablets daily, titrated according to the protocol; 2 to 4 tablets daily titrated according to the protocol
Intervention MeSH terms: Pyridoxine; Vitamin B 6; Doxylamine; Doxylamine succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 280.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nausea; Vomiting; Pregnancy; Hyperemesis gravidarum; Pregnancy complications

Summary:

      The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg
      and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of
      pregnancy than a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has signed a written informed consent to participate in the study and has
             agreed to follow dosing instructions and complete all required study visits.

          -  The patient is a pregnant female age equal to or greater than 18 years old.

          -  The patient's entry ultrasound indicates a viable pregnancy and confirms gestational
             age of the fetus is 7-14 weeks at the anticipated time of the first dose of study
             medication or placebo. If an ultrasound was done within 4 weeks of the admission
             visit, and results can be obtained, an additional ultrasound is not necessary.

          -  The patient is suffering from NVP and has a Pregnancy Unique Quantification of Emesis
             (PUQE) score ≥6.

          -  The patient has not responded to conservative management consisting of
             dietary/lifestyle advice according to the 2004 ACOG Practice Bulletin.

          -  The patient agrees, if on a multivitamin, to continue on their current dose of
             multivitamin for the duration of the trial.

          -  The patient does not plan termination of the pregnancy.

        Exclusion Criteria:

          -  The investigator confirms the patient's nausea and vomiting is of etiology other than
             Nausea and Vomiting of Pregnancy (NVP).

          -  The patient has gestational trophoblastic disease or multifetal gestation.

          -  The patient has a condition for which antihistamines, in the opinion of the
             investigator, are contraindicated (epilepsy, alcoholism, glaucoma, chronic lung
             disease, urinary retention, heart block, etc.).

          -  The patient has used antihistamines, anticholinergics, dopamine antagonists, serotonin
             antagonists, ginger, or anti-emetic therapy (including acupressure, acupuncture,
             homeopathic remedies, medical hypnosis, relief bands etc) to treat NVP in the previous
             48 hours or plans to do so during the study .

          -  The patient is using drugs that have anticholinergic activity (e.g., tricyclic
             antidepressants).

          -  The patient is taking multivitamins containing more than 10 mg of vitamin B6, or plans
             to do so during the study.

          -  The patient is taking supplementary vitamin B6 in addition to any multivitamin
             preparation, or plans to do so during the study.

          -  The patient is currently drinking any amount of alcohol.

          -  The patient has any condition that might interfere with the conduct of the study.

          -  The patient is likely to be unable to comply with study procedures because of
             inadequate cognitive skills.

          -  The patient 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.