The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
NCT ID: NCT00614445
Last Updated: 2021-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
280 participants
INTERVENTIONAL
2008-01-31
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Diclectin®
Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
up to 4 tablets daily, titrated according to the protocol
Placebo
Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
Placebo
2 to 4 tablets daily titrated according to the protocol
Interventions
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doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
up to 4 tablets daily, titrated according to the protocol
Placebo
2 to 4 tablets daily titrated according to the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Premier Research Group plc
UNKNOWN
Duchesnay Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Liubov Gargaun, M.D.
Role: STUDY_DIRECTOR
Duchesnay Inc.
Gideon Koren, M.D.
Role: PRINCIPAL_INVESTIGATOR
Motherisk Program, University of Toronto
Gary Hankins, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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Washington Hospital Center Physicians
Washington D.C., District of Columbia, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
National Naval Medical Center
Bethesda, Maryland, United States
Magee-Womens Hospital of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
UTMB Pasadena Clinic
Pasadena, Texas, United States
UTMB Regional Maternal & Child Health Program--Pearland Clinic
Pearland, Texas, United States
Countries
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References
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Persaud N, Meaney C, El-Emam K, Moineddin R, Thorpe K. Doxylamine-pyridoxine for nausea and vomiting of pregnancy randomized placebo controlled trial: Prespecified analyses and reanalysis. PLoS One. 2018 Jan 17;13(1):e0189978. doi: 10.1371/journal.pone.0189978. eCollection 2018.
Koren G, Clark S, Hankins GD, Caritis SN, Umans JG, Miodovnik M, Mattison DR, Matok I. Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. BMC Pregnancy Childbirth. 2016 Nov 24;16(1):371. doi: 10.1186/s12884-016-1172-9.
Koren G, Hankins GD, Clark S, Caritis SN, Miodovnik M, Umans JG, Mattison DR. Effectiveness of doxylamine-pyridoxine for morning sickness. Am J Obstet Gynecol. 2016 May;214(5):664-6. doi: 10.1016/j.ajog.2016.01.186. Epub 2016 Feb 1. No abstract available.
Koren G, Clark S, Hankins GD, Caritis SN, Umans JG, Miodovnik M, Mattison DR, Matok I. Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. BMC Pregnancy Childbirth. 2015 Mar 18;15:59. doi: 10.1186/s12884-015-0488-1.
Matok I, Clark S, Caritis S, Miodovnik M, Umans JG, Hankins G, Mattison DR, Koren G. Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs. J Clin Pharmacol. 2014 Dec;54(12):1429-33. doi: 10.1002/jcph.369. Epub 2014 Aug 7.
Costantine MM, Matok I, Chiossi G, Clark S, Miodovnik M, Umans JG, Caritis S, Hankins GD, Koren G. Determinants of adherence to delayed-release doxylamine and pyridoxine in patients with nausea and vomiting of pregnancy. Ther Drug Monit. 2012 Oct;34(5):569-73. doi: 10.1097/FTD.0b013e31826e7997.
Koren G, Clark S, Hankins GD, Caritis SN, Miodovnik M, Umans JG, Mattison DR. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol. 2010 Dec;203(6):571.e1-7. doi: 10.1016/j.ajog.2010.07.030. Epub 2010 Sep 16.
Other Identifiers
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DIC-301
Identifier Type: -
Identifier Source: org_study_id