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Doxylamine Hydrogen Succinate

This article discusses a clinical trial investigating the use of a fixed-dose combination of Doxylamine and Pyridoxine for treating nausea and vomiting in pregnancy (NVP). The study aims to assess the effectiveness of this medication in improving the quality of life for pregnant women experiencing these symptoms. The trial focuses on evaluating the drug’s impact over a 14-day period, considering various aspects such as symptom relief, patient satisfaction, and safety.

Table of Contents

What is Doxylamine/Pyridoxine?

Doxylamine/Pyridoxine is a combination medication used to treat nausea and vomiting in pregnancy (NVP). It consists of two main components[1]:

  • Doxylamine hydrogen succinate: An antihistamine that helps reduce nausea
  • Pyridoxine hydrochloride: Also known as vitamin B6, which can help alleviate nausea and vomiting

This medication is available as a modified-release capsule, which means it releases the active ingredients slowly over time for prolonged effect[1].

Medical Condition: Nausea and Vomiting of Pregnancy

Nausea and vomiting of pregnancy (NVP), also known as morning sickness, is a common condition that affects many pregnant women, typically during the first trimester[1]. Symptoms can range from mild to severe and can significantly impact a woman’s quality of life.

How Does Doxylamine/Pyridoxine Work?

The combination of doxylamine and pyridoxine works in two ways[1]:

  1. Doxylamine, an antihistamine, helps reduce nausea by blocking certain receptors in the brain.
  2. Pyridoxine (vitamin B6) is believed to help with the metabolism of certain compounds that may contribute to nausea and vomiting.

Dosage and Administration

The medication is typically taken as follows[1]:

  • Starting dose: 2 capsules at bedtime
  • If symptoms persist, the dose can be increased gradually
  • Maximum daily dose: 4 capsules (40 mg of each active ingredient)
  • Possible dosing schedules:
    • 0 capsules in the morning, 0 in the afternoon, 2 at night
    • 1 capsule in the morning, 0 in the afternoon, 2 at night
    • 1 capsule in the morning, 1 in the afternoon, 2 at night

The treatment duration in the study was 14 days, but your doctor will determine the appropriate length of treatment for your specific case[1].

Effectiveness of the Treatment

The effectiveness of Doxylamine/Pyridoxine is being evaluated in clinical trials. Some key points about its effectiveness include[1]:

  • The medication aims to improve the quality of life for pregnant women with NVP
  • Effects are measured after 7 and 14 days of treatment
  • Daily assessments of nausea and vomiting are conducted to track improvement
  • The onset and duration of the medication’s effect are evaluated

Safety and Side Effects

While Doxylamine/Pyridoxine is generally considered safe for use during pregnancy, it’s important to be aware of potential side effects and safety considerations[1]:

  • Common side effects may include drowsiness, dry mouth, or constipation
  • The medication should not be taken if you have certain conditions, such as porphyria or hypersensitivity to antihistamines
  • It may interact with other medications, so inform your doctor about all medicines you’re taking
  • Safety is continuously monitored during clinical trials through the reporting of adverse events

Who Can Use This Medication?

Doxylamine/Pyridoxine is specifically designed for pregnant women with nausea and vomiting. However, there are certain criteria for who can use this medication[1]:

  • Pregnant women aged 18-45 years
  • Gestational age between 5 and 12 weeks
  • Experiencing nausea and/or vomiting of pregnancy
  • Not planning to discontinue the pregnancy
  • Not taking high doses of vitamin B6 supplements

Some conditions may prevent you from using this medication, such as certain gastrointestinal diseases, severe NVP requiring hospitalization, or hypersensitivity to the ingredients[1].

Patient Satisfaction and Quality of Life

The clinical trial aims to evaluate how Doxylamine/Pyridoxine affects the quality of life for pregnant women with NVP. This includes[1]:

  • Assessing overall improvement in quality of life
  • Measuring patient satisfaction with the treatment
  • Evaluating the medication’s impact on daily activities and well-being

Remember, while this information provides an overview of Doxylamine/Pyridoxine for NVP, always consult with your healthcare provider for personalized medical advice and treatment options.

Aspect Details
Study Type Prospective, multicentre, open-label clinical trial
Medication Fixed-dose combination of Doxylamine and Pyridoxine 10/10 mg modified-release capsules
Target Population Pregnant women (18-45 years) with nausea and vomiting of pregnancy (NVP)
Main Objective Evaluate efficacy on quality of life after 14 days of treatment
Secondary Objectives Assess efficacy after 7 days, daily symptom changes, onset and duration of effect, safety, compliance, and satisfaction
Key Measurements NVPQoL scale, PUQE-24 scale, adverse events, compliance rates, patient and investigator satisfaction
Treatment Duration 14 days
Maximum Daily Dose 40 mg (combined Doxylamine and Pyridoxine)

FAQ

  • What is the purpose of this clinical trial? The main purpose of this trial is to evaluate how effective a combination of Doxylamine and Pyridoxine is in improving the quality of life for pregnant women experiencing nausea and vomiting. The study will look at the effects after 14 days of treatment.
  • Who can participate in this trial? Pregnant women aged 18-45 years, between 5 and 12 weeks of pregnancy, experiencing nausea and vomiting of pregnancy with a certain level of severity (PUQE intensity ≥6) can participate. There are other specific criteria for inclusion and exclusion in the study.
  • What does the treatment involve? The treatment involves taking Doxylamine/Pyridoxine 10/10 mg modified-release capsules. The dosage may be adjusted over the 14-day period according to the patient's needs, following specific guidelines.
  • How will the effectiveness of the treatment be measured? The effectiveness will be measured using various methods, including the NVPQoL scale (which assesses quality of life), the PUQE-24 scale (which measures the severity of nausea and vomiting), and patient and investigator satisfaction ratings.
  • Are there any safety concerns being monitored in this trial? Yes, the trial will monitor the safety of the treatment by tracking the incidence of adverse events and serious adverse events throughout the study period. The researchers will also evaluate the patients' compliance with the treatment regimen.

Ongoing Clinical Trials on Doxylamine Hydrogen Succinate

  • Study on Doxylamine and Pyridoxine for Pregnant Women with Nausea and Vomiting

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Nausea and Vomiting of Pregnancy (NVP): A common condition during pregnancy characterized by feelings of nausea and episodes of vomiting, often referred to as 'morning sickness' although it can occur at any time of day.
  • Doxylamine: An antihistamine medication that can help reduce nausea and vomiting.
  • Pyridoxine: Also known as Vitamin B6, it's a vitamin that may help reduce nausea and vomiting during pregnancy.
  • Modified-release capsules: A type of medication capsule designed to release the active ingredients slowly over time, providing a longer-lasting effect.
  • PUQE scale: Pregnancy-Unique Quantification of Emesis and Nausea scale, used to measure the severity of nausea and vomiting in pregnancy.
  • NVPQoL scale: Nausea and Vomiting of Pregnancy Quality of Life scale, used to assess how NVP affects a pregnant woman's quality of life.
  • Gestational age: The time elapsed since the first day of the last menstrual period, used to track the progress of a pregnancy.
  • Hyperemesis gravidarum: A severe form of nausea and vomiting during pregnancy that can lead to weight loss and dehydration.
  • Trophoblastic disease: A rare group of pregnancy-related tumors that can cause severe nausea and vomiting.

References

  1. http://clinicaltrials.eu/trial/study-on-doxylamine-and-pyridoxine-for-pregnant-women-with-nausea-and-vomiting/