Conditions: Nausea and Vomiting of Pregnancy
Keywords: Nausea Vomiting Pregnancy Hyperemesis gravidarum Pregnancy complications
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 280
Healthy volunteers: no

Brief 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.

Detailed description:
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 management of NVP for over 25 years and has been prescribed to over 33 million pregnant women.

Presently, there is no Food Drug and Administration (FDA) approved drug on the market to treat the symptoms of NVP. This study will test the efficacy of Diclectin® (doxylamine 10 mg, pyridoxine 10 mg in a delayed-release formulation) for NVP.

Patients enrolled in the study will receive between 2 and 4 tablets of Diclectin® or placebo daily, depending on their symptoms for up to 14 days. Patients will assess their symptoms of nausea and vomiting daily using a standardized questionnaire.

Arms:
arm 1: Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet arm 2: Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)

Interventions: intervention 1: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: up to 4 tablets daily, titrated according to the protocol intervention 2: 2 to 4 tablets daily titrated according to the protocol

Protocol document: