doxylamine has been researched along with Morning Sickness in 25 studies
Doxylamine: Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in PARKINSONISM.
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.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Doxylamine-pyridoxine is recommended as a first line treatment for nausea and vomiting during pregnancy and it is commonly prescribed." | 9.27 | Doxylamine-pyridoxine for nausea and vomiting of pregnancy randomized placebo controlled trial: Prespecified analyses and reanalysis. ( El-Emam, K; Meaney, C; Moineddin, R; Persaud, N; Thorpe, K, 2018) |
| " 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." | 9.19 | Studying 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) |
| "Our investigation showed ondansetron to be superior to the combination of pyridoxine and doxylamine in the treatment of nausea and emesis in pregnancy." | 9.19 | Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. ( Capp, SM; Carstairs, SD; Oliveira, LG; Riffenburgh, RH; You, WB, 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." | 9.14 | Effectiveness 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." | 7.80 | Should 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." | 7.79 | The 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." | 6.82 | Demonstration 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) |
| " We re-analyzed the 24 primary studies cited in a 1997 meta-analysis that concluded antihistamine use for NVP was safe as they had been studied in more than 200,000 participating women and the pooled odds ratio for congenital malformations was 0." | 6.50 | Re-analysis of safety data supporting doxylamine use for nausea and vomiting of pregnancy. ( Chin, JW; Gregor, S; Persaud, N, 2014) |
| "Doxylamine-pyridoxine is recommended as a first line treatment for nausea and vomiting during pregnancy and it is commonly prescribed." | 5.27 | Doxylamine-pyridoxine for nausea and vomiting of pregnancy randomized placebo controlled trial: Prespecified analyses and reanalysis. ( El-Emam, K; Meaney, C; Moineddin, R; Persaud, N; Thorpe, K, 2018) |
| " 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." | 5.19 | Studying 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) |
| "Our investigation showed ondansetron to be superior to the combination of pyridoxine and doxylamine in the treatment of nausea and emesis in pregnancy." | 5.19 | Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. ( Capp, SM; Carstairs, SD; Oliveira, LG; Riffenburgh, RH; You, WB, 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." | 5.14 | Effectiveness 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) |
| " The NVP Healthline enrolled two control groups of women with NVP treated with a doxylamine-pyridoxine combination for morning sickness." | 5.11 | Is lack of morning sickness teratogenic? A prospective controlled study. ( Boskovic, R; Danieliewska-Nikiel, B; Koren, G; Navioz, Y; Rudic, N, 2004) |
| "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." | 3.80 | Should 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." | 3.79 | The 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." | 2.82 | Demonstration 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) |
| " We re-analyzed the 24 primary studies cited in a 1997 meta-analysis that concluded antihistamine use for NVP was safe as they had been studied in more than 200,000 participating women and the pooled odds ratio for congenital malformations was 0." | 2.50 | Re-analysis of safety data supporting doxylamine use for nausea and vomiting of pregnancy. ( Chin, JW; Gregor, S; Persaud, N, 2014) |
| "Of note, co-existing gastroesophageal reflux disease (GERD), Helicobacter pylori infection, and psychosocial factors may have a negative impact on the management of NVP." | 2.50 | The outpatient management and special considerations of nausea and vomiting in pregnancy. ( Clark, SM; Dutta, E; Hankins, GD, 2014) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 3 (12.00) | 29.6817 |
| 2010's | 20 (80.00) | 24.3611 |
| 2020's | 2 (8.00) | 2.80 |
| Authors | Studies |
|---|---|
| MacDuffie, KE | 1 |
| Kleinhans, NM | 1 |
| Stout, K | 1 |
| Wilfond, BS | 1 |
| Kennedy, DS | 1 |
| Batagol, RP | 1 |
| Persaud, N | 3 |
| Meaney, C | 1 |
| El-Emam, K | 1 |
| Moineddin, R | 1 |
| Thorpe, K | 1 |
| Koren, G | 12 |
| Matok, I | 3 |
| Umans, J | 1 |
| Feghali, MN | 1 |
| Clark, S | 5 |
| Caritis, S | 2 |
| Miodovnik, M | 5 |
| Hankins, G | 2 |
| Mattison, DR | 5 |
| Nordeng, H | 1 |
| Chin, JW | 1 |
| Gregor, S | 1 |
| Hansen, KA | 1 |
| Slaughter, SR | 1 |
| Hearns-Stokes, R | 1 |
| van der Vlugt, T | 1 |
| Joffe, HV | 1 |
| Chin, J | 1 |
| Walker, M | 1 |
| Umans, JG | 4 |
| Oliveira, LG | 1 |
| Capp, SM | 1 |
| You, WB | 1 |
| Riffenburgh, RH | 1 |
| Carstairs, SD | 1 |
| Clark, SM | 1 |
| Dutta, E | 1 |
| Hankins, GD | 4 |
| Maltepe, C | 3 |
| Madjunkova, S | 1 |
| Cunningham, K | 1 |
| Oliveira, L | 1 |
| Capp, S | 1 |
| Pope, E | 1 |
| Caritis, SN | 3 |
| Dyer, O | 1 |
| Niebyl, JR | 1 |
| Boskovic, R | 1 |
| Rudic, N | 1 |
| Danieliewska-Nikiel, B | 1 |
| Navioz, Y | 1 |
| Staroselsky, A | 1 |
| Garcia-Bournissen, F | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy[NCT00614445] | Phase 3 | 280 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022[NCT06055192] | 200 participants (Anticipated) | Observational | 2023-09-30 | Not yet recruiting | |||
| Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy[NCT01668069] | 36 participants (Actual) | Interventional | 2012-10-31 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
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)
| Intervention | PUQE Score (Mean) |
|---|---|
| Diclectin® | -4.8 |
| Placebo | -3.9 |
3 reviews available for doxylamine and Morning Sickness
| Article | Year |
|---|---|
Re-analysis of safety data supporting doxylamine use for nausea and vomiting of pregnancy.
Topics: Antiemetics; Congenital Abnormalities; Doxylamine; Female; Humans; Morning Sickness; Odds Ratio; Pre | 2014 |
The outpatient management and special considerations of nausea and vomiting in pregnancy.
Topics: Ambulatory Care; Antiemetics; Diet Therapy; Doxylamine; Female; Fluid Therapy; Gastroesophageal Refl | 2014 |
Clinical practice. Nausea and vomiting in pregnancy.
Topics: Adult; Chorionic Gonadotropin; Complementary Therapies; Diagnosis, Differential; Dicyclomine; Doxyla | 2010 |
8 trials available for doxylamine and Morning Sickness
| Article | Year |
|---|---|
Doxylamine-pyridoxine for nausea and vomiting of pregnancy randomized placebo controlled trial: Prespecified analyses and reanalysis.
Topics: Doxylamine; Drug Therapy, Combination; Female; Humans; Morning Sickness; Placebos; Pregnancy; Pyrido | 2018 |
Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs.
Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Double-Blind Method; Doxylamine; Drug Combina | 2014 |
Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial.
Topics: Adult; Antiemetics; Double-Blind Method; Doxylamine; Drug Therapy, Combination; Female; Follow-Up St | 2014 |
Comparing pyridoxine and doxylamine succinate-pyridoxine HCl for nausea and vomiting of pregnancy: A matched, controlled cohort study.
Topics: Adult; Antiemetics; Cohort Studies; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Morn | 2015 |
Effectiveness of doxylamine-pyridoxine for morning sickness.
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.
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.
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.
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.
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.
Topics: Adult; Delayed-Action Preparations; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Meth | 2010 |
Is lack of morning sickness teratogenic? A prospective controlled study.
Topics: Adult; Antiemetics; Congenital Abnormalities; Doxylamine; Female; Genetic Counseling; Humans; Matern | 2004 |
14 other studies available for doxylamine and Morning Sickness
| Article | Year |
|---|---|
Protection Versus Progress: The Challenge of Research on Cannabis Use During Pregnancy.
Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Ethics, Research; Female; Hu | 2020 |
Confusion about doxylamine safety in pregnancy.
Topics: Antiemetics; Australia; Doxylamine; Female; Humans; Morning Sickness; Pregnancy | 2021 |
The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women.
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.
Topics: Adult; Dicyclomine; Double-Blind Method; Doxylamine; Drug Combinations; Female; Histamine H1 Antagon | 2013 |
Diclegis: return of a medication.
Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Female; Humans; Morning Sick | 2013 |
FDA approval of doxylamine-pyridoxine therapy for use in pregnancy.
Topics: Antiemetics; Congenital Abnormalities; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Fe | 2014 |
Should doxylamine-pyridoxine be used for nausea and vomiting of pregnancy?
Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans | 2014 |
Treating morning sickness in the United States--changes in prescribing are needed.
Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Female; Heart Defects, Conge | 2014 |
Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial.
Topics: Doxylamine; Female; Humans; Morning Sickness; Ondansetron; Pregnancy; Pyridoxine | 2015 |
Odansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial.
Topics: Doxylamine; Female; Humans; Morning Sickness; Ondansetron; Pregnancy; Pyridoxine | 2015 |
In reply.
Topics: Doxylamine; Female; Humans; Morning Sickness; Ondansetron; Pregnancy; Pyridoxine | 2015 |
Flawed invisible trial underpins US morning sickness drug, researchers say.
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.
Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Gastrointestinal Agents; Gastrointe | 2007 |
Preventing recurrence of severe morning sickness.
Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Morning Sickness; Ondansetr | 2006 |