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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00614445 |
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Date of registration:
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29/01/2008 |
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Primary sponsor: |
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Public title:
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The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
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Scientific title:
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A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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280 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00614445 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Liubov Gargaun, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duchesnay Inc. |
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Name:
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Gideon Koren, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Motherisk Program, University of Toronto |
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Name:
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Gary Hankins, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Nausea and Vomiting of Pregnancy
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Intervention(s)
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Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
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Drug: Placebo
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Primary Outcome(s)
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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)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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