Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for nausea and vomiting of pregnancy, a common condition experienced by many pregnant women. The treatment being tested is a combination of two substances: doxylamine hydrogen succinate and pyridoxine hydrochloride, which are provided in a capsule form that releases the medication slowly over time. The purpose of the study is to evaluate how this treatment affects the quality of life for pregnant women dealing with nausea and vomiting.

Participants in the study will take the medication for a period of 14 days. During this time, researchers will monitor changes in the participants' symptoms and overall well-being. The study aims to understand how the treatment impacts the severity and frequency of nausea and vomiting, as well as how it influences the participants' daily lives. The study will also assess the safety of the treatment by keeping track of any side effects that may occur.

Throughout the study, participants will be asked to provide feedback on their experiences with the treatment, including how quickly they notice any effects and how satisfied they are with the results. This information will help researchers determine the effectiveness of the treatment and its potential benefits for improving the quality of life for pregnant women experiencing nausea and vomiting.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. This includes being a pregnant adult woman aged 18-45 years, with a gestational age between 5 and 12 weeks, and experiencing nausea and vomiting of pregnancy.
Informed consent is required to participate in the study and to follow the administration instructions of the investigational product.
Step 2
Medication administration
The treatment involves taking a fixed-dose combination of doxylamine and pyridoxine in 10 mg/10 mg modified-release hard capsules.
The medication is taken orally, with a dosage regimen that may vary: morning-afternoon-night posology of 0-0-2, 1-0-2, or 1-1-2 capsules, depending on the response to treatment.
Step 3
Treatment duration
The treatment is administered over a period of 14 days.
The primary goal is to evaluate the improvement in quality of life after 14 days of treatment.
Step 4
Evaluation after 7 days
After 7 days of treatment, an evaluation is conducted to assess changes in the quality of life score related to nausea and vomiting.
The evolution of symptoms is monitored daily using a specific scale.
Step 5
Evaluation after 14 days
After completing 14 days of treatment, a final evaluation is conducted to assess the overall improvement in symptoms and quality of life.
The frequency and severity of nausea and vomiting are analyzed, along with the patient's satisfaction with the treatment.
Step 6
Safety and compliance monitoring
Throughout the study, any adverse events are recorded to ensure the safety of the treatment.
Therapeutic compliance is assessed to determine how well the treatment regimen is followed.

Who can join the trial?

6 criteria

The participant must be a pregnant adult woman aged between 18 and 45 years.
The participant should be between 5 and 12 weeks of pregnancy. This means the pregnancy should be between the start of the 5th week and the end of the 12th week. The pregnancy should have been confirmed with an ultrasound before joining the study.
The participant must be experiencing **nausea and vomiting of pregnancy**. This means feeling sick or actually vomiting due to pregnancy. The intensity of these symptoms should be at a level of 6 or higher on a specific scale called **PUQE**.
The participant should not have plans to end the pregnancy.
The participant must have signed a form agreeing to take part in the study. This form is called **informed consent**. The participant should also agree to follow the instructions for taking the study medication and attend all study visits.
The participant should not have taken the medication **Doxylamine/Pyridoxine** for treating nausea and vomiting in pregnancy before. If the participant has taken it before joining the study, it should not have been more than a daily dose of 20/20 mg. This will be checked for the 5 days before joining the study.

Who cannot join the trial?

8 criteria

Patients who are not pregnant cannot participate.
Patients who are not experiencing nausea and vomiting during pregnancy cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are male cannot participate, as the study is only for females.
Patients who have any medical condition that the study doctors think might interfere with the study cannot participate.
Patients who are taking medications that might interfere with the study treatment cannot participate.
Patients who have allergies to the study medication or its ingredients cannot participate.
Patients who are unable to follow the study procedures cannot participate.

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Verified sites

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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Santa Caterina Ias
Verified
Salt, Spain

Trial locations

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Investigated drugs

Doxylamine
is a medication used in this trial to help reduce nausea and vomiting in pregnant women. It is often used in combination with other medications to improve its effectiveness in managing these symptoms.
Pyridoxine
, also known as Vitamin B6, is used alongside doxylamine in this trial. It helps to alleviate nausea and vomiting during pregnancy, contributing to an improved quality of life for the participants.

What is already known about the treatment

Doxylamine and Pyridoxine – This medication is administered orally in the form of modified-release capsules. It is currently being studied in clinical trials to assess its effectiveness in improving the quality of life for pregnant women experiencing nausea and vomiting. The main therapeutic indication for this combination is to alleviate nausea and vomiting during pregnancy. At the molecular level, doxylamine works as an antihistamine, blocking histamine receptors, while pyridoxine, a form of vitamin B6, helps in metabolic processes that may reduce nausea. This combination is classified pharmacologically as an antiemetic, specifically targeting pregnancy-related symptoms.

Investigated diseases

Nausea and Vomiting of Pregnancy – This condition, often referred to as morning sickness, is characterized by nausea and vomiting that occur during pregnancy. It typically begins in the first trimester and can vary in intensity from mild to severe. The exact cause is not fully understood, but it is believed to be related to hormonal changes in the body. Symptoms can occur at any time of the day, despite the common name. While it usually improves as the pregnancy progresses, some women may experience symptoms throughout their pregnancy. The condition can impact daily activities and quality of life, but it is generally considered a normal part of pregnancy.