Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A prospective, multicentre open-label clinical trial to evaluate the efficacy of the fixed-dose combination of Doxylamine and Pyridoxine 10/10 mg modified-release capsules on the quality of life of pregnant women presenting with nausea and vomiting of pregnancy (NVP).

This research is looking into how effective a specific medication, Cariban (a combination of Doxylamine and Pyridoxine in a 10mg/10mg slow-release capsule), is for pregnant women experiencing morning sickness. The main goal is to see if it significantly improves their quality of life after two weeks of treatment. Researchers will also check for improvements after just one week, track how their nausea and vomiting change day-to-day, and find out if women are taking the medicine as prescribed. They'll also monitor the medicine's safety, how quickly it starts working, and how satisfied women are with the treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Itf Research Pharma S.L.

Enrolment target

Start

12 Sep 2023

Nausea and vomiting of pregnancy

What is this study about?

This study is investigating a common issue many women face during pregnancy: morning sickness, also known as nausea and vomiting of pregnancy (NVP). While this can often be mild, for some, it can be quite distressing and impact their daily life. The study wants to explore how a specific medication called Cariban, which contains two ingredients (Doxylamine and Pyridoxine) in a slow-release capsule, can help with these symptoms.

The main aim is to understand if this medicine can improve the overall quality of life for pregnant women battling morning sickness. Researchers will compare how women feel before starting the treatment to how they feel after 14 days of taking Cariban. They will use special questionnaires designed to measure the impact of nausea and vomiting on daily life.

Beyond simply feeling better, the study will also track other important aspects. This includes how daily symptoms of nausea and vomiting change over time, how well women stick to their medication schedule, how quickly the medicine starts to work and how long its effects last. They will also keep a close eye on any side effects and gather feedback on how satisfied women are with the treatment. All of this information helps doctors understand if this medicine is a good choice for pregnant women with morning sickness.

Key takeaways

The study investigates Cariban for morning sickness in pregnant women.
It aims to improve quality of life for women with nausea and vomiting in pregnancy.
Participation involves taking the study drug daily for 14 days.
Researchers will track symptom changes and any side effects.
The study is for adult pregnant women experiencing morning sickness.

Who may be eligible?

To join this study, you need to be an adult woman, aged 18 or older, and currently, pregnant. The study is specifically looking for women who are experiencing nausea and vomiting due to their pregnancy.

There might be other specific health conditions or medications that would prevent you from taking part, but the main criteria are being an adult, pregnant, and experiencing morning sickness symptoms.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently pregnant?
Are you experiencing nausea and/or vomiting due to your pregnancy?
Are you able to take study medication for 14 days?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking the study medication, Cariban 10mg/10mg slow-release capsules, over a period of 14 days. During this time, you will be in close contact with the study team. You'll be asked to complete questionnaires and assessments, likely at the start of the study, after 7 days, and again after 14 days. This will help us understand how your symptoms and quality of life are changing. You might also be asked to keep a daily record of your nausea and vomiting. The study team will monitor your progress, check for any side effects, and ensure you're taking the medication as prescribed. The exact number of visits or phone calls will be explained by the study team.

Potential risks and benefits

Participating in a study like this might offer a potential benefit if the study medication helps to relieve your nausea and vomiting, potentially improving your quality of life. However, there's no guarantee the treatment will work for you, and like all medications, Cariban can have side effects. These will be fully explained to you before you decide to take part. Researchers will closely monitor your health throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is morning sickness?

Morning sickness, also known as nausea and vomiting of pregnancy (NVP), is common during pregnancy and can include feeling sick (nausea) and actually being sick (vomiting).

What is Cariban?

Cariban is a medicine being studied. It's a capsule that contains two ingredients, Doxylamine and Pyridoxine, designed to help relieve nausea and vomiting.

How long will I take the medicine for?

If you join the study, you would take the study medicine for 14 days.

Will I have to visit the clinic often?

You will have a few visits or check-ins. The study team will explain the full schedule of appointments and how often you'll need to be in contact with them.

Who is running this study?

This is a clinical trial involving several medical centres, meaning different hospitals or clinics are taking part in the research.