The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

Launched by DUCHESNAY INC. · Jan 30, 2008

Keywords

ClinConnect Summary

Nausea and vomiting of pregnancy (NVP), also known as "morning sickness," is a common condition that affects a large percentage of pregnant women. The symptoms can range from mild nausea to severe nausea and vomiting for which a woman may need to be hospitalized. Nausea and vomiting of pregnancy can affect a woman's quality of life and ability to conduct daily activities.

Diclectin® is a combination of 10 mg doxylamine succinate (an antihistamine), and 10 mg pyridoxine hydrochloride (vitamin B6) in a delayed release tablet formulation. It has been commercially available in Canada for the m...

Gender

FEMALE

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.