The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by:
Duchesnay Inc.
ClinicalTrials.gov Identifier:
NCT00614445
First received: January 29, 2008
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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
Nausea and Vomiting of Pregnancy
Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

Resource links provided by NLM:


Further study details as provided by Duchesnay Inc.:

Primary Outcome Measures:
  • Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15). [ Time Frame: Baseline (Day 1) to End of Study Visit Day 15 (± 1 day) ] [ Designated as safety issue: No ]
    The objective of this double-blind, randomized, placebo-controlled study was to assess the efficacy, safety, and tolerability of oral Diclectin® in the treatment of nausea and vomiting of pregnancy (NVP) as measured by the Pregnancy Unique-Quantification of Emesis (PUQE) overall score of symptoms from baseline (Day 1) to end of study visit (Day 15). The PUQE score measured hours of nausea, number of times vomiting, and number of times retching for a TOTAL overall score of symptoms on a scale rated from 3 (no symptoms) to 15 (most severe).


Enrollment: 280
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclectin®
Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
up to 4 tablets daily, titrated according to the protocol
Other Name: Diclectin®
Placebo Comparator: Placebo
Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
Drug: Placebo
2 to 4 tablets daily titrated according to the protocol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614445

Locations
United States, District of Columbia
Washington Hospital Center Physicians
Washington, District of Columbia, United States, 20010
Georgetown University Hospital
Washington, District of Columbia, United States, 20057
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889
United States, Pennsylvania
Magee-Womens Hospital of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
UTMB Pasadena Clinic
Pasadena, Texas, United States, 77502
UTMB Regional Maternal & Child Health Program--Pearland Clinic
Pearland, Texas, United States, 77581
Sponsors and Collaborators
Duchesnay Inc.
Premier Research Group plc
Investigators
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
  More Information

No publications provided by Duchesnay Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liubov Gargaun, M.D., Duchesnay, Inc.
ClinicalTrials.gov Identifier: NCT00614445     History of Changes
Other Study ID Numbers: DIC-301
Study First Received: January 29, 2008
Results First Received: August 1, 2011
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Duchesnay Inc.:
Nausea
Vomiting
Pregnancy
Hyperemesis gravidarum
Pregnancy complications

Additional relevant MeSH terms:
Nausea
Vomiting
Pregnancy Complications
Signs and Symptoms, Digestive
Signs and Symptoms
Doxylamine
Doxylamine succinate
Pyridoxine
Vitamin B 6
Pyridoxal
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014