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Sponsors and Collaborators: |
Duchesnay Inc. Premier Research Group plc |
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Information provided by: | Duchesnay Inc. |
ClinicalTrials.gov Identifier: | NCT00614445 |
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.
Condition | Intervention | Phase |
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Nausea and Vomiting of Pregnancy |
Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy |
Estimated Enrollment: | 280 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Diclectin®: Experimental
Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
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Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
up to 4 tablets daily, titrated according to the protocol
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Placebo: Placebo Comparator
Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
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Drug: Placebo
2 to 4 tablets daily titrated according to the protocol
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hoang Nguyen | 919-806-0612 | NVP.Pregnancy@premier-research.com |
United States, District of Columbia | |
Washington Hospital Center Physicians | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Principal Investigator: Menachem Miodovnik, M.D. | |
United States, Pennsylvania | |
Magee-Womens Hospital of University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Principal Investigator: Steve N. Caritis, M.D. | |
United States, Texas | |
University of Texas Medical Branch | Recruiting |
Galveston, Texas, United States, 77555-0587 | |
Principal Investigator: Gary DV Hankins, M.D. |
Study Director: | Liubov Gargaun, M.D. | Duchesnay Inc. |
Principal Investigator: | Gideon Koren, M.D. | Motherisk Program, University of Toronto |
Principal Investigator: | Gary Hankins, M.D. | University of Texas |
Responsible Party: | Duchesnay, Inc. ( Liubov Gargaun, M.D. ) |
Study ID Numbers: | DIC-301 |
Study First Received: | January 29, 2008 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00614445 |
Health Authority: | United States: Food and Drug Administration |
Nausea Vomiting Pregnancy Hyperemesis gravidarum Pregnancy complications |
Hyperemesis Gravidarum Doxylamine succinate Signs and Symptoms Vomiting Pregnancy Complications Signs and Symptoms, Digestive |
Doxylamine Histamine phosphate Pyridoxine Nausea Vitamin B 6 Histamine |
Neurotransmitter Agents Vitamin B Complex Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Gastrointestinal Agents Histamine Agents Antiemetics Pharmacologic Actions |
Histamine Antagonists Autonomic Agents Vitamins Therapeutic Uses Histamine H1 Antagonists Micronutrients Peripheral Nervous System Agents Central Nervous System Agents |