The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

NCT00614445 | Completed Phase 3 Results

• 1 other identifier: DIC-301
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 7

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.

Conditions

Nausea and Vomiting of Pregnancy

Keywords

Nausea; Vomiting; Pregnancy; Hyperemesis gravidarum; Pregnancy complications

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

  Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)

Study Arms (2)

Diclectin®

EXPERIMENTAL

Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet

Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg

Placebo

PLACEBO COMPARATOR

Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)

Drug: Placebo

Interventions

doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg DRUG

up to 4 tablets daily, titrated according to the protocol

Also known as: Diclectin®

Diclectin®

Placebo DRUG

2 to 4 tablets daily titrated according to the protocol

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duchesnay Inc.: lead
• Premier Research: collaborator

Study Sites (7)

Washington Hospital Center Physicians

Washington D.C., District of Columbia, 20010, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20057, United States

Location

National Naval Medical Center

Bethesda, Maryland, 20889, United States

Location

Magee-Womens Hospital of University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

UTMB Pasadena Clinic

Pasadena, Texas, 77502, United States

Location

UTMB Regional Maternal & Child Health Program--Pearland Clinic

Pearland, Texas, 77581, United States

Location

Related Publications (7)

• 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.

  PMID: 29342163 DERIVED

• 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.

  PMID: 27881103 DERIVED

• 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.

  PMID: 26844757 DERIVED

• 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.

  PMID: 25884778 DERIVED

• 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.

  PMID: 25052410 DERIVED

• 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.

  PMID: 22972538 DERIVED

• 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.

  PMID: 20843504 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting; Hyperemesis Gravidarum; Pregnancy Complications

Interventions

doxylamine succinate; Pyridoxine; dicyclomine, doxylamine, pyridoxine drug combination

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Morning Sickness; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michael Gallo
• Organization: Duchesnay, Inc.

mgallo@duchesnay.com

450-433-7734

Study Officials

• Liubov Gargaun, M.D.

  Duchesnay Inc.

  STUDY DIRECTOR

• Gideon Koren, M.D.

  Motherisk Program, University of Toronto

  PRINCIPAL INVESTIGATOR

• Gary Hankins, M.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 23, 2021
• Results First Posted: September 5, 2011

Record last verified: 2011-08

Locations

US (7)