The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duchesnay Inc.
• Collaborator: Premier Research Group plc
• Treatments: Dicyclomine; Dicyclomine, doxylamine, pyridoxine drug combination; Doxylamine; Doxylamine succinate; Pyridoxal; Pyridoxine; Vitamin B 6

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.