This study will answer the following research question:
Is acutaping has therapeutic implications on symptoms of nausea and vomiting during pregnancy?

Start Date03 Feb 2023

Sponsor / Collaborator

Kafrelsheikh University

CTR20202295 / CompletedPhase 3

评价琥珀酸多西拉敏片治疗短期失眠的有效性和安全性的多中心、随机、双盲、安慰剂、平行对照III期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled, parallel-controlled phase III clinical trial to evaluate the efficacy and safety of doxylamine succinate tablets in the treatment of short-term insomnia

1. 与安慰剂相比，通过多导睡眠仪监测受试者入睡潜伏期，评价琥珀酸多西拉敏片治疗短期失眠的有效性。 2. 探索琥珀酸多西拉敏片治疗短期失眠的临床最佳剂量。 3. 评价琥珀酸多西拉敏片治疗短期失眠的安全性。

[Translation]

1. To evaluate the effectiveness of doxylamine succinate tablets in the treatment of short-term insomnia by monitoring the subjects' sleep latency through polysomnography compared with placebo. 2. To explore the optimal clinical dose of doxylamine succinate tablets in the treatment of short-term insomnia. 3. To evaluate the safety of doxylamine succinate tablets in the treatment of short-term insomnia.

Start Date21 May 2021

Sponsor / Collaborator

Suzhou No. 4 Pharmaceutical Factory

[+1]

ChiCTR2000032596 / SuspendedNot ApplicableIIT

Acupuncture and/or Diclectin Treatment for Nausea and Vomiting of Pregnancy : A Two by Two factorial Trial (NVPAct)

Start Date01 Oct 2020

Sponsor / Collaborator-

100 Clinical Results associated with Doxylamine Succinate

100 Translational Medicine associated with Doxylamine Succinate

100 Patents (Medical) associated with Doxylamine Succinate

723

Literatures (Medical) associated with Doxylamine Succinate

01 Feb 2024·Journal of hazardous materials

Oxidation of amine-based pharmaceuticals with unactivated peroxymonosulfate: Kinetics, mechanisms, and elimination efficiency of NDMA formation

Article

Author: Zeng, Zhu ; Fu, Junhao ; Gao, Yuan ; Zhou, Yang ; Zhang, Zhong ; Ma, Jinxing ; Han, Bin ; Jiang, Jin

Amine-based pharmaceuticals are a significant class of N-nitrosodimethylamine (NDMA) precursors. This study investigated the use of unactivated peroxymonosulfate (PMS) to control amine-based pharmaceuticals and their NDMA formation potential. Kinetic analysis and product identification revealed that sumatriptan and doxylamine primarily underwent reactions at their tertiary amine group, while ranitidine and nizatidine had both tertiary amine and thioether group as reaction sites. The NDMA formation from sumatriptan and doxylamine during post-chloramination was significantly reduced with the abatement of the parent contaminants, while the formation of NDMA remained high even if full abatement of ranitidine and nizatidine was achieved. Product formation kinetics and reference standard tests revealed the great contribution of transformation products to NDMA formation. Ranitidine could be oxidized to sulfoxide-type product ranitidine-SO and N-oxide type product ranitidine-NO. Ranitidine-SO exhibited a high NDMA yield comparable to that of ranitidine (>90%), while ranitidine-NO showed a low NDMA yield (2%). With further oxidation of ranitidine-SO at the tertiary amine group, NDMA formation was reduced by more than 90%. The underlying mechanism for the importance of the tertiary amine group in NDMA formation was demonstrated by quantum chemical calculation. These findings underscore the potential of PMS pre-oxidation on NDMA control.

01 Jan 2024·Advances in therapy

Standardized Extract of Valeriana officinalis Improves Overall Sleep Quality in Human Subjects with Sleep Complaints: A Randomized, Double-Blind, Placebo-Controlled, Clinical Study

Article

Author: Joshua, Lincy ; Chandra Shekhar, Harshith ; Thomas, Jestin V

INTRODUCTION:

Sleep deficit or poor sleep leads to ill-health, whereas sleep deprivation for longer periods of time increases the risk of developing adverse conditions associated with poor quality of life, and high socioeconomic impact. The treatments for sleep disturbances include melatonin and over-the-counter medicines like diphenhydramine and doxylamine, all of which have negative side effects. Valerian (Valeriana officinalis L.) is a traditional herb and the most preferred alternate sleep solution to manage sleep complaints.

METHODS:

Eighty adult subjects with sleep complaints were randomized in 1:1 ratio to receive either V. officinalis extract (VE) or placebo for 8 weeks in a double-blind, placebo-controlled, parallel, clinical study. Primary efficacy endpoints included the Pittsburgh Sleep Quality Index (PSQI) and sleep latency using wrist actigraphy (WA), as well as a number of secondary endpoints, including sleep parameters such as actual sleep time and sleep efficiency using WA, the Epworth Sleepiness Scale (ESS), the Beck Anxiety Inventory (BAI), the Visual Analogue Scale (VAS) for the feeling of waking up refreshed, and a tertiary endpoint of sleep parameters using polysomnography (PSG) in a subset of 20 subjects per group. Safety parameters included physical examination, vital sign measurements, hematology, and clinical chemistry tests. Adverse events and serious adverse events were monitored throughout the study period.

RESULTS:

Seventy-two subjects (35 and 37 subjects in the placebo and VE groups, respectively) completed the study and were included in the efficacy assessments. On Days 14, 28, and 56, the PSQI Total Score in the VE group decreased significantly (p < 0.05) compared to the placebo group. Further, the VE group showed significant improvements (p < 0.05) in sleep latency and actual sleep time on Days 3, 14, 28, and 56, and sleep efficiency on Days 14, 28, and 56, as evaluated by WA. There was a decrease (p < 0.05) in anxiety (BAI) on Days 14, 28, and 56, daytime drowsiness (ESS) on Days 28 and 56, and an increased feeling of waking up refreshed (VAS) on Days 28 and 56 compared to placebo. PSG results carried out in subset of subjects revealed significant improvements (p < 0.05) in total sleep time, sleep latency, and sleep efficiency on Day 56 in the VE group compared to the placebo group. No safety concerns were observed throughout the study.

CONCLUSION:

VE supplementation significantly improved various subjective and objective parameters of sleep in young subjects with mild insomnia symptoms, such as overall sleep quality, sleep latency, sleep efficiency, and total sleep time. We also observed decreased anxiety and daytime sleepiness, and improved feeling of being refreshed after waking up with VE supplementation. VE was found to be safe and well tolerated throughout the study.

TRIAL REGISTRATION:

Clinical Trials Registry of India: CTRI/2022/05/042818.

01 Sep 2023·Drug testing and analysis

Incorporation of doxylamine and N‐doxylamine‐oxide in human hair and the impact of a permanent oxidative hair dye

Article

Author: Wille, Sarah M. R. ; Ramirez Fernandez, Maria del Mar ; Samyn, Nele

Abstract:

Knowledge of the drug incorporation in hair and impact of cosmetic treatments remains essential to correctly interpret forensic cases. The study shows the analysis of doxylamine and doxylamine‐N‐oxide and the evaluation of the relationship between dose and hair concentration and the impact of hair treatment (oxidative dying). The study included (A) three subjects participated to the study: a regular user (Subject 1) and two single‐dose users (Subject 2, 1 single dose; and Subject 3, 2 single doses spaced 5 months apart). Subject 3 applied a permanent oxidative hair dying monthly. (B) A permanent oxidative hair dying was applied twice to the hair collected from Subject 2. (A) The average concentrations in head hair for doxylamine and its N‐doxylamine‐oxide, respectively, were as follows: Subject 1, 1825 pg/mg and 16 pg/mg; Subject 2, 182 and <limit of quantification (LOQ); and Subject 3, Strand 1 (1 month after last single dose]; 1st cm: 367 pg/mg and 22 pg/mg; 2nd cm: 664 pg/mg and 37 pg/mg; 3rd cm 108 pg/mg and 13 pg/mg; 4th cm 13 pg/mg and 7 pg/mg); Strand 2 (5 months after last single dose: <LOQ). (B) The oxidative hair dying increased the concentration of the metabolite from undetected <LOQ up to 79 pg/mg (n = 3, RSD 6%). The concentration of the parent drug decreased from 128 pg/mg to 40 pg/mg (n = 3, RSD 4%). This is the first time the incorporation of doxylamine and its metabolite was evaluated with adequate and controlled information concerning dose and timing of ingestion for the evaluation of their incorporation and the impact of a cosmetic treatment.

News (Medical) associated with Doxylamine Succinate

10 May 2024

·www.fiercehealthcare.com

New specialty care provider Harmonia Healthcare opens clinic to treat extreme morning sickness

Harmonia Healthcare's chief scientific officer, Marlena Fejzo, Ph.D., will also leverage her groundbreaking discovery of the hormone associated with HG to drive innovations in prognostics, prevention and treatments. Harmonia Healthcare, a new provider focused on specialty women’s health, has opened a clinic in New Jersey to treat hyperemesis gravidarum (HG). HG can bring nausea and vomiting during pregnancy severe enough to prevent proper food intake and can lead to weight loss, dehydration and ultimately hospitalization. It can cause complications for mothers and their babies and is estimated to affect up to nearly 11% of pregnant women. Harmonia’s new clinic will offer evidence-based treatments and educate patients on the latest science around HG. Its offerings include medication and vitamin infusion, electrolyte replacement plans, prescription management, diagnostic bloodwork and telehealth. A second clinic is planned to open in New York City this fall. The clinic does not require referrals. Its chief scientific officer, Marlena Fejzo, Ph.D., a women’s health researcher with lived experience of HG, will also leverage her and colleagues' groundbreaking discovery of the hormone associated with the condition—GDF15—to drive innovations in prognostics, prevention and treatment. Fejzo was a 2023 Fiercest Women in Life Sciences awardee. “We really want to fix the broken care model in women’s health and improve care,” Fejzo told Fierce Healthcare. “We hope to expand this to be the future of care for these undertreated and underdiagnosed diseases.” Harmonia’s online platform will offer educational resources and eventually telehealth, though women should still ideally first come into the clinic in person. The current status quo for women with HG is unacceptable and costly, Fejzo says. If they end up in an emergency room, they are treated with fluids or antiemetic drugs and released. But because HG causes persistent nausea and vomiting, women need persistent medication management, Fejzo argues. If they are discharged without a prescription, many will inevitably wind up back in the hospital again; 60% of women have multiple hospital visits, per Fejzo. And, while HG is starting to be diagnosed properly more often, Fejzo said, it can still be misdiagnosed or not diagnosed at all. “A lot of people think that it’s just regular nausea and vomiting and that everything’s going to be fine … when actually there are really adverse outcomes associated with HG for the mother and the baby,” Fejzo said. During a recent conference, Fejzo said she discovered ER doctors affiliated with Harvard discharge HG patients without a prescription. Their justification for it was that the medications might make them tired, and then they would have to miss work. “That’s a real misunderstanding of HG,” Fejzo said, adding that if Harvard-affiliated docs are doing it, “I assume it is common.” RELATED: New study finds cause and potential treatment for dangerous morning sickness Part of the reason Fejzo believes this is happening is due to a famous historic incident known as the thalidomide disaster. After women being treated with thalidomide for nausea had babies with birth defects, it launched a widespread hesitancy to prescribe medications during pregnancy, Fejzo said. There also remains a misguided belief that HG is psychological or resolves on its own. And because HG typically starts early in pregnancy, many women see ER docs before even seeing their obstetrician, meaning many providers may not be aware of how sick their patients have really been. Obstetricians are also generally not trained to ask their patients about their levels of nausea and vomiting—and patients, too, may not talk about it, Fejzo explained. To address this, Harmonia will be monitoring women receiving medication management and coordinating with their other providers, like OB-GYNs, midwives and doulas. The goal is to intervene as early as possible with more aggressive treatment before the condition spirals out of control. The best medications for HG being prescribed off-label include Zofran, Phenergan and Reglan, according to Fejzo. Yet doctors usually begin with doxylamine and pyridoxine, as recommended by the American College of Obstetricians and Gynecologists, which Fejzo says are “pretty much a placebo for HG.” By serving patients with HG, Harmonia will have the infrastructure in place to run clinical trials on potential new treatments, Fejzo said. She is already advising NGM Bio, which recently announced it is interested in testing its drug NGM120 in HG patients. While Fejzo doesn’t anticipate challenges with patients getting their scripts filled, Harmonia providers will educate patients on how to have conversations with pharmacists in case they do run into pushback. In recent years, pharmacists have sometimes refused to fill opioid prescriptions with doses they perceived as too high or poorly monitored by the prescriber. One of the country’s only other clinics in this space, Alabama’s Morning Sickness Clinic, claims its model has led to a 95% reduction in ER visits and a 90% decrease in total cost of care. Its co-founder, an emergency medicine physician, is one of Harmonia’s clinical advisers. Harmonia eventually hopes to expand to serve other under-researched women’s health conditions. While the company does not currently plan to pursue formal health system partnerships, it hopes that its clinics will come to be known locally as the go-to expert for these conditions. And, while it isn’t yet, Harmonia plans to be working with commercial and Medicaid insurance plans by the end of this year.

11 May 2023

·www.drugs.com

The Most Common Allergy Medicines

THURSDAY, May 11, 2023 -- If you suffer from allergies, you know how bothersome and uncomfortable the sneezing and itchy eyes can be. These symptoms are more than irritating — they impact day-to-day activities like work, school, sports, sleeping and even eating. Not only that, but allergies can also cause more serious health problems such as asthma and even anaphylaxis, a life-threatening allergic reaction. Allergies are a common health condition affecting almost one-third of adults in the United States and just over one-quarter of children under 17, according to the U.S. Centers for Disease Control and Prevention . But there is relief at hand: Here’s what you need to know about the most common allergy medicines, the type of allergies they treat, how they work and common side effects. Antihistamines This type of allergy medicine is very effective in relieving allergy symptoms. Mayo Clinic explains this drug type works by blocking histamine, “a symptom-causing chemical released by your immune system during an allergic reaction.” Antihistamines are available as an over-the-counter medication or as a prescription allergy medicine, and they are sold in oral form, as a nasal spray or as eyedrops. This allergy medicine treats symptoms of indoor and seasonal allergies. Common side effects of antihistamines include drowsiness, dry mouth, dizziness, blurred or double vision, mucous thickening and low blood pressure. Common antihistamines include: Oral Loratadine (Alavert, Claritin) Cetirizine (Zyrtec) Diphenhydramine (Benadryl) Doxylamine (Vicks NyQuil, Tylenol Cold and Cough Nighttime) Fexofenadine (Allegra) Nasal spray Olopatadine (Patanase) Eyedrops Ketotifen (Zaditor) Leukotriene modifiers Leukotriene modifiers prevent or lessen the symptoms of allergic rhinitis (hay fever) and allergic asthma. The Cleveland Clinic explains that leukotrienes are chemicals released in the body when you come in contact with an allergen. This causes symptoms like a runny nose and coughing. Leukotriene inhibitors block the effects leukotrienes have on the body or “stop your body from producing them.” This allergy medicine treats symptoms of indoor and seasonal allergies. Leukotriene inhibitors can cause side effects such as cold or flu symptoms, headache, diarrhea, fatigue and itchy skin or rash. More serious side effects like depression, thoughts of suicide, hives, trouble breathing, vomiting and yellowing of the skin or eyes can occur. You should seek medical treatment in these cases. Common leukotriene inhibitors include: Montelukast (Singulair) Zafirlukast (Accolate) Zileuton (Zyflo) Corticosteroids Corticosteroids treat mild to severe allergy symptoms by reducing inflammation caused by your body’s reaction to an allergen. Corticosteroids are available in several forms including pills and liquids, nasal sprays, inhalers, creams and eyedrops. They treat allergic inflammation caused by indoor and seasonal allergens as well as insect stings. Severe allergic reactions are treated with oral corticosteroids, according to the Mayo Clinic. Side effects vary depending on the medication form, but can include increased blood glucose levels, high blood pressure, nosebleeds, mouth and throat irritation, and skin irritation. Common corticosteroids by form include: Pills and liquids Prednisolone (Prelone) Methylprednisolone (Medrol) Nasal sprays Budesonide (Rhinocort) Mometasone (Nasonex) Inhalers Fluticasone (Flovent) Mometasone (Asmanex Twisthaler) Creams Betamethasone (Dermabet, Diprolene) Desonide (Desonate, DesOwen) Eyedrops Fluorometholone (Flarex, FML) Loteprednol (Alrex, Lotemax) Immunotherapy Immunotherapy works by modifying the immune system and its reaction to allergens. It’s not used for immediate allergy symptom relief but is a long-term allergy treatment. Immunotherapy treatments (or allergy shots) are prescription medicines. "Allergy shots can be helpful for patients with seasonal and year-round allergies," Miranda Curtiss , an assistant professor at the University of Alabama at Birmingham School of Medicine, said in a recent article . "However, these are a long-term investment that require planning to continue therapy for three to five years for maximal benefit. Asthmatics who want to start allergy shots need to have their asthma under good control first before starting shots." With allergy shots, you are exposed to an allergen over and over until your immune system becomes desensitized and no longer reacts to the allergen, the Mayo Clinic says. This type of treatment is commonly given as allergy shots (subcutaneous immunotherapy, or SCIT), but is also available in a form given under the tongue (sublingual immunotherapy, or SLIT). With SCIT, injections are given in your doctor’s office where they can monitor for adverse reactions. Treatment starts with the “build-up phase,” which is once or twice a week, and decreases to a maintenance dose which is once every two to four weeks. Sublingual immunotherapy treatment, like subcutaneous immunotherapy, also exposes you to allergens over a period of time, with the goal of building immunity to the allergen. SLIT tablets are available by prescription and taken daily. Immunotherapy is used to treat seasonal and indoor allergies, as well as insect stings. Side effects include watery eyes, sneezing, mild asthma symptoms, a rash at the injection site, tiredness and headaches. In rare cases, life-threatening reactions such as throat swelling and difficulty breathing can occur. Regardless of the type of allergy or your symptoms, there are options for relief. Reach out to your health care provider to learn more about which remedies are best for you. Posted May 2023

Immunotherapy

28 Mar 2023

·www.drugs.com

Higher Risk for CRC Seen in Adults Exposed to Bendectin In Utero

TUESDAY, March 28, 2023 -- Adults exposed in utero to the antiemetic Bendectin (doxylamine/pyridoxine/dicyclomine), prescribed during pregnancy in the 1960s, have an increased risk for colorectal cancer (CRC), according to a study published online March 10 in JNCI Cancer Spectrum . Caitlin C. Murphy, Ph.D., M.P.H., from the University of Texas Health Science Center at Houston School of Public Health, and colleagues examined the association between in utero exposure to Bendectin and the risk for CRC in adult offspring (aged 18 years and older) from the Child Health and Development Studies multigenerational cohort, which included 14,507 mothers and 18,751 liveborn offspring. Overall, about 5 percent of offspring were exposed to Bendectin in utero. The researchers found that exposed offspring had a higher risk for CRC compared with unexposed offspring (adjusted hazard ratio, 3.38). For offspring exposed and unexposed to Bendectin, the incidence rates of CRC were 30.8 and 10.1 per 100,000, respectively. "Our findings suggest medications prescribed to pregnant women in the 1960s may, in part, contribute to recent increases in incidence rates of CRC. As the burden of CRC continues to increase in the U.S. and worldwide, well-conducted experimental studies will be critical to clarify these findings and identify mechanisms of risk," the authors write. "Testing for associations with in utero exposure to dicyclomine-containing medications still used during pregnancy may also be warranted." Two authors disclosed financial ties to the biopharmaceutical industry. Abstract/Full Text Posted March 2023

Clinical Result

100 Deals associated with Doxylamine Succinate

External Link

KEGG	Wiki	ATC	Drug Bank
D02327	Doxylamine Succinate	R06AA09	DB00366

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypersensitivity	US	Sanofi-Aventis U.S. LLC	07 Apr 1948
Morning Sickness	US	Sanofi-Aventis U.S. LLC	07 Apr 1948
Sleep Initiation and Maintenance Disorders	US	Sanofi-Aventis U.S. LLC	07 Apr 1948

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00290732 (CTgov)	Phase 1	Invasive Mammary Carcinoma	20	Doxil TM+Dox-SL (Intraductal Arm)	lvukmfowrh(ydzfdvmdvy) = sceimyefyo fbnrhggdur (gnqgouowqq, jigolpywco - eguafvnlwm)	-	26 Sep 2013
				Intravenous arm (Intravenous Arm)	sbjdocrutl(eqbiilcqdi) = cpvcrkxboe mecmxruhcx (ztmdaolhhe, ncurdblnsk - xiqvpadedj) View more
NCT00796315 (CTgov)	Phase 1	Rhinitis, Allergic	41	Doxylamine Succinate (Subjects Aged 2-5 Years)	xkpnkuwwmv(qzzsiplutm) = odmzzjtnes bkkupxqrnu (clqwasrnfa, wrjqkpfbzt - zbmtqidppr) View more	-	25 Jan 2013
				Doxylamine Succinate (Subjects Aged 6-11 Years)	xkpnkuwwmv(qzzsiplutm) = ocxkbzodco bkkupxqrnu (clqwasrnfa, osjfudoorm - hjwgunigac) View more

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