Page last updated: 2024-10-26

dicyclomine and Morning Sickness

dicyclomine has been researched along with Morning Sickness in 16 studies

Dicyclomine: A muscarinic antagonist used as an antispasmodic and in urinary incontinence. It has little effect on glandular secretion or the cardiovascular system. It does have some local anesthetic properties and is used in gastrointestinal, biliary, and urinary tract spasms.
dicyclomine : The ester resulting from the formal condensation of 1-cyclohexylcyclohexanecarboxylic acid with 2-(diethylamino)ethanol. An anticholinergic, it is used as the hydrochloride to treat or prevent spasm in the muscles of the gastrointestinal tract, particularly that associated with irritable bowel syndrome.

Morning Sickness: Symptoms of NAUSEA and VOMITING in pregnant women that usually occur in the morning during the first 2 to 3 months of PREGNANCY. Severe persistent vomiting during pregnancy is called HYPEREMESIS GRAVIDARUM.

Research Excerpts

ExcerptRelevanceReference
" This was a pre-specified substudy of a randomized, placebo-controlled trial comparing the antiemetic effect of the doxylamine-vitamin B6 combination (Diclectin®) (n = 131) to placebo (n = 126) in women with nausea and vomiting of pregnancy."9.19Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs. ( Caritis, S; Clark, S; Hankins, G; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2014)
"To evaluate the effectiveness of Diclectin (doxylamine succinate 10 mg-pyridoxine hydrochloride 10 mg, delayed-release preparation) as compared with placebo for nausea and vomiting of pregnancy."9.14Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Mattison, DR; Miodovnik, M; Umans, JG, 2010)
"Doxylamine-pyridoxine is the first-line agent for the treatment of nausea and vomiting of pregnancy (NVP) according to Canadian guidelines, and this combination is commonly prescribed to pregnant women."7.80Should doxylamine-pyridoxine be used for nausea and vomiting of pregnancy? ( Chin, J; Persaud, N; Walker, M, 2014)
"The US FDA approval in April 2013 of Diclegis®, the doxylamine-pyridoxine combination for morning sickness, is a major milestone, particularly since it is indicated for use in pregnancy and the FDA has labeled it a pregnancy category A drug the strongest evidence of fetal safety."7.79The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women. ( Koren, G, 2013)
" Study drug dosing occurred for 14 days, which is substantially longer than what has been performed in similar studies."6.82Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2016)
" This was a pre-specified substudy of a randomized, placebo-controlled trial comparing the antiemetic effect of the doxylamine-vitamin B6 combination (Diclectin®) (n = 131) to placebo (n = 126) in women with nausea and vomiting of pregnancy."5.19Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs. ( Caritis, S; Clark, S; Hankins, G; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2014)
"To evaluate the effectiveness of Diclectin (doxylamine succinate 10 mg-pyridoxine hydrochloride 10 mg, delayed-release preparation) as compared with placebo for nausea and vomiting of pregnancy."5.14Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Mattison, DR; Miodovnik, M; Umans, JG, 2010)
"Doxylamine-pyridoxine is the first-line agent for the treatment of nausea and vomiting of pregnancy (NVP) according to Canadian guidelines, and this combination is commonly prescribed to pregnant women."3.80Should doxylamine-pyridoxine be used for nausea and vomiting of pregnancy? ( Chin, J; Persaud, N; Walker, M, 2014)
"The US FDA approval in April 2013 of Diclegis®, the doxylamine-pyridoxine combination for morning sickness, is a major milestone, particularly since it is indicated for use in pregnancy and the FDA has labeled it a pregnancy category A drug the strongest evidence of fetal safety."3.79The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women. ( Koren, G, 2013)
" Study drug dosing occurred for 14 days, which is substantially longer than what has been performed in similar studies."2.82Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2016)

Research

Studies (16)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (12.50)29.6817
2010's13 (81.25)24.3611
2020's1 (6.25)2.80

Authors

AuthorsStudies
MacDuffie, KE1
Kleinhans, NM1
Stout, K1
Wilfond, BS1
Koren, G10
Matok, I3
Umans, J1
Feghali, MN1
Clark, S5
Caritis, S2
Miodovnik, M5
Hankins, G2
Mattison, DR5
Nordeng, H1
Hansen, KA1
Slaughter, SR1
Hearns-Stokes, R1
van der Vlugt, T1
Joffe, HV1
Persaud, N1
Chin, J1
Walker, M1
Umans, JG4
Pope, E1
Maltepe, C2
Hankins, GD3
Caritis, SN3
Dyer, O1
Niebyl, JR1
Staroselsky, A1
Garcia-Bournissen, F1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022[NCT06055192]200 participants (Anticipated)Observational2023-09-30Not yet recruiting
A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy[NCT00614445]Phase 3280 participants (Actual)Interventional2008-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

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). (NCT00614445)
Timeframe: Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)

InterventionPUQE Score (Mean)
Diclectin®-4.8
Placebo-3.9

Reviews

1 review available for dicyclomine and Morning Sickness

ArticleYear
Clinical practice. Nausea and vomiting in pregnancy.
    The New England journal of medicine, 2010, Oct-14, Volume: 363, Issue:16

    Topics: Adult; Chorionic Gonadotropin; Complementary Therapies; Diagnosis, Differential; Dicyclomine; Doxyla

2010

Trials

5 trials available for dicyclomine and Morning Sickness

ArticleYear
Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs.
    Journal of clinical pharmacology, 2014, Volume: 54, Issue:12

    Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Double-Blind Method; Doxylamine; Drug Combina

2014
Comparing pyridoxine and doxylamine succinate-pyridoxine HCl for nausea and vomiting of pregnancy: A matched, controlled cohort study.
    Journal of clinical pharmacology, 2015, Volume: 55, Issue:7

    Topics: Adult; Antiemetics; Cohort Studies; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Morn

2015
Effectiveness of doxylamine-pyridoxine for morning sickness.
    American journal of obstetrics and gynecology, 2016, Volume: 214, Issue:5

    Topics: Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Morning Sic

2016
Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy.
    BMC pregnancy and childbirth, 2016, 11-24, Volume: 16, Issue:1

    Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

2016
Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial.
    American journal of obstetrics and gynecology, 2010, Volume: 203, Issue:6

    Topics: Adult; Delayed-Action Preparations; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Meth

2010
Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial.
    American journal of obstetrics and gynecology, 2010, Volume: 203, Issue:6

    Topics: Adult; Delayed-Action Preparations; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Meth

2010
Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial.
    American journal of obstetrics and gynecology, 2010, Volume: 203, Issue:6

    Topics: Adult; Delayed-Action Preparations; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Meth

2010
Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial.
    American journal of obstetrics and gynecology, 2010, Volume: 203, Issue:6

    Topics: Adult; Delayed-Action Preparations; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Meth

2010

Other Studies

10 other studies available for dicyclomine and Morning Sickness

ArticleYear
Protection Versus Progress: The Challenge of Research on Cannabis Use During Pregnancy.
    Pediatrics, 2020, Volume: 146, Issue:Suppl 1

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Ethics, Research; Female; Hu

2020
The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women.
    Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique, 2013, Volume: 20, Issue:2

    Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations;

2013
Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial.
    Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology, 2013, Volume: 33, Issue:6

    Topics: Adult; Dicyclomine; Double-Blind Method; Doxylamine; Drug Combinations; Female; Histamine H1 Antagon

2013
Diclegis: return of a medication.
    South Dakota medicine : the journal of the South Dakota State Medical Association, 2013, Volume: 66, Issue:12

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Female; Humans; Morning Sick

2013
FDA approval of doxylamine-pyridoxine therapy for use in pregnancy.
    The New England journal of medicine, 2014, Mar-20, Volume: 370, Issue:12

    Topics: Antiemetics; Congenital Abnormalities; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Fe

2014
Should doxylamine-pyridoxine be used for nausea and vomiting of pregnancy?
    Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC, 2014, Volume: 36, Issue:4

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

2014
Treating morning sickness in the United States--changes in prescribing are needed.
    American journal of obstetrics and gynecology, 2014, Volume: 211, Issue:6

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Female; Heart Defects, Conge

2014
Flawed invisible trial underpins US morning sickness drug, researchers say.
    BMJ (Clinical research ed.), 2017, Jan-09, Volume: 356

    Topics: Antiemetics; Clinical Trials as Topic; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Fe

2017
American Gastroenterological Association institute medical position statement on the use of gastrointestinal medication in pregnancy.
    Gastroenterology, 2007, Volume: 132, Issue:2

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Gastrointestinal Agents; Gastrointe

2007
Preventing recurrence of severe morning sickness.
    Canadian family physician Medecin de famille canadien, 2006, Volume: 52, Issue:12

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Morning Sickness; Ondansetr

2006