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Clinical study on the

Diabetic or idiopathic gastroparesis/ gastric emptying disorder

Do you have an excessive feeling of fullness after eating? Do you suffer from nausea, vomiting, abdominal pain, and loss of appetite?

We are looking for patients between the ages of 18 and 75 with diabetic or idiopathic gastroparesis/stomach emptying disorder for a clinical study.
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To register for the study, five questions must be answered in advance.

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More information

Study information

Phase IIb

18-75 years

Film-coated tablet

Possible symptoms and consequences of gastroparesis:

  • Feeling of fullness after eating
  • Nausea
  • Vomiting
  • Upper abdominal pain
  • Flatulence
  • Weight loss

What is gastroparesis?

It is a stomach disease in which food is digested more slowly than normal. In a healthy digestive system, powerful muscle contractions transport the food bolus from the stomach further through the intestinal tract. In gastroparesis, the muscles work more slowly or no longer work at all and as a result, the stomach cannot adequately empty.

Diabetic gastroparesis: Diabetic gastroparesis is a complication of diabetes mellitus.

Idiopathic gastroparesis: Idiopathic gastroparesis is defined as gastroparesis without an identifiable cause. This means that it is not the result of existing diseases.

Treatment and more

Important info

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Treatment

You will be randomly assigned to one of the four treatment groups. Three treatment groups receive study tablets with an active substance at different dosages. The fourth group receives placebo (tablets without active substance).

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Time required

Maximum length of treatment per patient: approx. 12 weeks.

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Aim of the study

In this study, the efficacy of the study drug (film-coated tablet) as compared to placebo is to be investigated during a 12-week treatment phase. In addition, the optimal dosage, safety, and tolerability will be evaluated.

You will be randomly assigned to one of the four treatment groups. Three treatment groups receive study tablets with an active substance at different dosages. The fourth group receives placebo (tablets without active substance).

Maximum length of treatment per patient: approx. 12 weeks.

In this study, the efficacy of the study drug (film-coated tablet) as compared to placebo is to be investigated during a 12-week treatment phase. In addition, the optimal dosage, safety, and tolerability will be evaluated.

Eligibility check

Check here whether you could be suitable for the gastroparesis study. You have to answer five questions.

Eligibility Check

Clinical study: gastroparesis

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FAQ Clinical Studies

Frequently asked questions

What are clinical trials?

A clinical trial is "any investigation involving human subjects", that tests new medical treatmentsdrugs or therapies to determine their safety and efficacy.

Why are clinical trials important?

Clinical trials are crucial for the development and validation of new medical approaches, to enable advances in healthcare and improve existing treatments.

Why should I participate in a clinical trial?

As a clinical trial participant, you will receive continuous, intensive medical care from an expert team of experienced physicians physicians and medical staff, who are always for She is reachable. This enables more detailed Examinations than your standard medical care. They also gain access to new Therapy optionslong before they were available on the market. available are. By your willingness to participate, you will make an important contribution to the development of the Therapy options of tomorrow and enable thus also provide other people with an improved prospect of treatment options.

What are the types of clinical trials?

Clinical trials are generally divided into several types: Observational studies, in which researchers observe and measure health outcomes without intervening, e.g. studies for digital health applications (DiGA); intervention studies, in which researchers test a drug, surgical procedure, or other treatment; and diagnostic studies, which focus on better ways to detect specific disorders or diseases. Each type aims to answer specific questions about health and treatment.

What is the difference between a randomized and a non-randomized clinical trial?

In randomized trials, participants are randomly assigned to a treatment group (e.g. drug A and B). assigned, to ensure that the investigator's influence is not reflected in the study results. In some cases however on Randomization waived be. Dann is a non-randomized study and the allocation is assigned on the basis of a specific principle.

What does the term “double-blind study” mean?

In a double-blind study, neither the participants nor the the investigatorwhich group (treatment group or control group) a participant belongs to, in order to avoid any bias in the study results. bias in the results of the study. the results of the study.

Who can participate in a clinical trial?

Eligibility criteria may vary by study. Typically, participants are selected based on certain factors such as age, gender, medical history, and the presence of specific diseases. Each study has its own inclusion and exclusion criteria.

How can I participate in a clinical trial?

If you are interested in participating, you should first research what studies are pending for your specific condition or area of interest. You should then contact the researchers or clinical trial center for more information and to see if you meet eligibility requirements.

What are inclusion criteria and why are they important?

Inclusion criteria are certain characteristics that a participant must meet to be eligible for a study. They help ensure that the study provides relevant results.

Are there any exclusion criteria that could disqualify me from participating in a study?

Yes, exclusion criteria may include factors that could affect the safety or accuracy of study results.s. These are also certain characteristics that a participant should not meet, such as other preexisting conditions, etc.

Where are clinical trials conducted?

Clinical trials take place in so-called trial centers. These may be, for example, physicians' offices or clinics and are facilities that have the necessary equipment and personnel trained for the study and are specialized in conducting studies. An investigator trained to conduct clinical trials is responsible for ensuring that the study is conducted according to protocol and that the patient is fully informed.

What rights do I have as a participant in a clinical trial?

As a participant, you have the right to be fully informed about the study, including potential risks and benefits. You may terminate your participation at any time without affecting your medical care. All personal information is treated confidentially.

Do I have the right to end my participation in a clinical trial at any time?

Yes, participation is always voluntary and you can stop it at any time without negative consequences.

What happens if I decide not to participate?

Participation in clinical trials is voluntary, and your decision not to participate will not affect your medical care or your relationship with the doctors and researchers.

What are the benefits of a clinical trial for me?

If you are ready declareto become part of a clinical trial support It thus supports medical research in the search for innovative and more effective therapies and drugs. With this you can you can help other patients in the near future treatment options and thus make a direct contribution to the medical progress of society. By taking part in a clinical trial, you yourself have the Possibilitynew and more effective active ingredients before they are available on the market. available are. In addition you will during intensively cared for by medical staff throughout the study and receive a variety of additional examinations, such as precise blood tests, ECGs, blood pressure measurements, etc. Thus can you yourself also benefit health-wise from participating. You will also receive information about the current state of medical research in the field of your complaints and diseases.

How do I find a suitable trial site to participate in a clinical trial?

Information on current studies and trial sites can be found at medical centers, research institutions or online databases. On the portal Future for Patients you will find current available studies.

How does a clinical trial work?

Clinical trials are conducted not only in hospitals, but also by physicians in private practice. Pharmaceutical companies are often the clients of such studies, but universities or hospitals can also initiate such studies. An educational interview will be conducted prior to potential participation. Here you will be informed about goals, methods, advantages and possible risks. After sufficient time to think about it, you can decide whether you want to participate in the clinical trial. Participation is always voluntary and can be terminated at any time without giving reasons. The initial consultation will be followed by the screening visit, during which your eligibility for the study will be assessed. If the assessment is positive, the baseline visit occurs, in which baseline values are recorded and then the study medication or a placebo is administered. During the treatment phase, regular visits are scheduled to monitor your health, the effectiveness of the medication, and any side effects. After the treatment phase, there is a follow-up phase to evaluate the long-term effects and safety of the medication.

How will I be informed about the potential risks and benefits of participating in the study?

Before you choose for Decide to participate in a study, will guide you through the process. the investigator will conduct an intensive educational discussion about the course of the study. You will explainswhich advantages you have through the study and which possible Risks exist. You will receive a detailed and written description of your clinical picture and informationen üabout the commonalready anerkennt treatment optionstions. You will the also about it that you can stop participating in the study at any time.the study wider callsn canwithout any disadvantages arising for you. After sufficient time to think about it, you sign and the Prüfarzt a Erklärung and profess, that the Recconversation stattgefunthe has. FFor Your persersonal Receive documents at home You the outuch Patient information and your Agreementsrklärung.

Will there be any costs for me during the study?

No, all for treatments and medications necessary for the study are for You for free. In many studies, you will also receive travel reimbursement and a Expense allowance. For more details will be provided by the responsible investigator at educational interview explain.

Will I receive compensation for my participation in a clinical trial?

The participation of healthy volunteers in phase I studies is in principle remunerated. However, even in the other phases of the study, patients usually receive a Remuneration. This is dependent on various factors dependent. For this include among other things the possible risk and the time involved. In addition to the reimbursement of travel expenses, it is commonthat patients receive lump-sum reimbursements for receive individual visits or the entire study. Depending on the type of study, special expenses (special examinations, more time required) will also be remunerated. Please inform yourself with the respective contact person for the study according to the exact amount of the remuneration.

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What actually is gastroparesis?

More about the disease pattern