Do you have gastroparesis?

If the answer is yes, then you might be able to participate in a clinical research study. This study is testing the safety and effectiveness of an investigational medication for people with diabetic or idiopathic gastroparesis.

What is Gastroparesis?

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Gastroparesis is a condition that affects the normal motility (movement) of the stomach. When motility is slowed down or abnormal, the regular function of the stomach is changed.

This can interfere with digestion and cause a variety of troublesome symptoms. Individuals with gastroparesis may experience the following symptoms:

  • Nausea
  • Feeling full after only eating a few bites
  • Bloating
  • Vomiting
  • Abdominal pain
  • Fluctuating blood sugar levels
  • Lack of appetite
  • Weight loss
  • Lack of nutrition

These symptoms can have a major effect on daily activities and overall quality of life.

Currently, there is no cure for gastroparesis and there are limited options to treat the symptoms and improve quality of life. The few medical and surgical options for individuals with gastroparesis have been limited by the potential for side effects so far. None of the recognized drug treatment options are designed for daily use over long periods of time.

We are looking for adults who have certain digestive issues or have been diagnosed with gastroparesis to participate in a clinical research study.

About the Avanzar Study

We are looking for adults with gastroparesis to participate in a clinical research study. This study will test the safety and effectiveness of a new investigational medication for the symptoms of this chronic condition.
Study participants must have gastroparesis that has an unknown cause (idiopathic) or that has been caused by diabetes.
We are looking for around 280 people to participate in this global study.

Learn more

Answer a short questionnaire to find out if you qualify to participate in our gastroparesis clinical research study.

Do I Qualify For This Study?

If you have gastroparesis and are interested in participating in this study, you first need to see if you qualify by answering some questions that can be accessed here.

If your responses to the questions meet the basic study requirements, and you’ve agreed to share your contact information (name, phone number, and email), then the study center closest to your location will call you. During this call you will be asked some more questions to see if you meet additional study requirements. If the study team member determines that your responses further qualify you for the study, and you are still interested in participating, then you will schedule your first appointment to visit the study center for additional medical screening.

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What Can I Expect If I Participate?

At your first study center visit, you will be asked to review and to sign an informed consent document. This document contains detailed information about the study, including what will be expected of you if you participate. Once this consenting process is complete, the study team will begin the “screening process”. You can expect to be examined by the medical team, and you will receive additional tests to see if you meet the medical requirements of the study.

The requirements at this point in the qualifying process are scientifically based. Once testing is completed and your results are reviewed, the study team will determine if you meet the requirements for study entry. A study team member will contact you to confirm whether or not you can proceed with study participation. This screening process can take approximately 5 weeks.

If you still agree to move forward and want to join the study, you can expect to participate at no cost. This means that you will receive all study-related medical care and study medications without any cost to you. You may also receive reimbursement for meals, time, and travel to the study center as part of your participation.

If you sign the informed consent and the screening process results match the Avanzar study requirements, you can expect the following: 

  • Study participation will last approximately 17 weeks.
  • You will be asked to take one capsule in the morning and one capsule at night every day. There will be 4 possible capsule options you could receive – 1 of 3 active doses or a placebo. The placebo looks like the investigational medication but does not contain the active ingredient. You will be randomly assigned (like flipping a coin) to 1 of the 4 options. Neither you nor the study team will know which option you have been assigned to. The study doctor can find out If necessary for health reasons.
  • As a participant, you will need to visit the study center about seven (7) times over the 17-week time period.
  • During these visits, you will receive medical exams and tests, have blood samples collected, and be asked to complete a series of questionnaires.
  • You will be asked to keep an electronic daily diary that captures gastroparesis symptoms, study medication dosing, meal information and other medication use while you participate in the study.
  • 40 days after receiving the last dose of study medication, a study team member will follow up to ask a few questions and to answer any of your remaining questions.

A mobile app to help you understand this trial. Get the app here.

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What is Clinical Research?

Simply defined, Clinical Research uses scientific methods in a highly regulated setting to study human health and disease. Researchers need clinical trials to expand medical knowledge and to discover new treatments or procedures that help to treat, and in some instances, cure medical conditions.

Clinical studies help find new and better ways to detect, diagnose, treat, and prevent disease. Without clinical trials, we would not have vaccines that prevent common illnesses, antibiotics to treat infections, over-the-counter pain medicines, tests that detect cancer, or devices that regulate heartbeats, just to name a few.

Clinical trials are designed for different purposes. They aim to find new or better ways to:

  • Detect health and disease conditions
  • Diagnose illness and medical conditions
  • Improve quality of life for people suffering with an illness
  • Prevent disease from occurring or reoccurring
  • Discover healthy behaviors that help alleviate or prevent disease
  • Measure the effectiveness of the treatment
  • Treat diseases with new drugs or new combinations of drugs

The primary focus of a clinical trial is to determine whether a medical strategy, treatment or device is:

  • Efficacious: Researchers need to determine if a new treatment is effective
  • Safe: Every drug has side effects. During the trial researchers closely monitor whether those side effects outweigh the treatment benefits.

Additional information about Clinical Research can be found here.

Why is Clinical Study Participation Important?

When it comes to clinical trial participation, it’s important to know that:

  • When you participate, you are advancing medical knowledge that could help you and others with the disease or condition.
  • Most of the time, the treatment being tested and the related medical care are provided at no cost to you. You may even be reimbursed for your time and travel.
  • You may have access to the study medication that may not be widely available yet.

The goal of clinical research is to improve human health by finding better ways to prevent, diagnose, and treat the disease.

Clinical trial participants make medical breakthroughs possible. Without participants:

  • No new medications get to patients
  • No simpler or quicker diagnostic tools are identified
  • No improved treatment options are discovered

Join other research volunteers. Take a quick survey & learn if you qualify now.

What are the Phases of Drug Development?

When researchers think a new drug or treatment may bring benefit to patients, they start to design a clinical trial. Before a new drug or treatment is available to the public, it must first go through multiple phases of research to ensure that it is both safe and effective. This process takes time and, more importantly, relies on people like you to help.

For studies conducted in the US, research data from each phase of drug development is shared with the FDA (Food and Drug Administration), the regulatory agency that analyzes the data and determines whether the drug, treatment, or device gets approved to go on the market in the US. Many countries have similar regulatory agencies or bodies that oversee the conduct of clinical trials.

Read more about the phases below:

Answer a short questionnaire to find out if you qualify to participate in our gastroparesis clinical research study.

Frequently Asked Questions

During a clinical study, if you are a part of the study treatment group you will receive the actual study drug that is being studied. There is also a possibility that you may be part of the control group, which means you will receive a placebo, or a medication that looks like the study drug being studied but does not contain the active ingredient. Both groups are closely monitored by the study team. Data is captured and analyzed from the study treatment group and compared to the data from the control group.

As a study participant, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study medication.

All study volunteers are closely monitored by the study’s medical team to ensure their safety at all times.

Clinical trials are all about the participants. To participate in a trial, you must meet certain requirements called “inclusion criteria”. The inclusion factors may be qualities you have no control over, such as disease diagnosis, or medical history. The study may be looking for people who suffer from a specific aliment – or looking for people with no history of that ailment in their or their family’s medical history.

You may have all the desired inclusion factors and still not be able to participate if you have one or more “exclusion factors”- conditions that are not allowed for the study.

It’s important not to get discouraged if you are excluded from a study. Clinical research is science based, and protocols are strict to ensure the right people are asked to participate.

You have the right to ask any questions at any time as part of the study participation experience. Here are some questions you may want to ask:

  • What will this drug be used for?
  • What are the risks?
  • What are the benefits?
  • What is expected of me for this study? 
  • How long does the study last?

Informed Consent is a process that explains the details of the study, including the potential risks and benefits, as well as your rights and responsibilities. You will receive facts and information about the study that will help you decide if you want to participate. The Informed Consent explains the possible side effects you may experience if you receive the drug being tested. It is important to remember that study participation is voluntary. Anyone can decide to stop at any time without reason even after the informed consent form is signed.

Every clinical trial must be reviewed and monitored by an Institutional Review Board (IRB) or Ethics Committee (EC) to make sure the risks are as low as possible and are worth any potential benefits to the volunteer. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled to.

A Principal Investigator (PI) is the doctor in charge of preparing for and carrying out the clinical research study. Each study site has its own PI who is fully responsible for providing oversight for members of the study team and ensuring the safety of all study participants.

A placebo looks like the study drug being tested, but it doesn’t have any active ingredients. In placebo-controlled research, one group is given the inactive treatment, while another group is given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.

During the informed consent process, you and a study team member will go over all the study details including any potential risks. It’s important to be aware that while participating in a clinical research study, your condition may stay the same, may get worse, or may improve. While the study doctors will watch you closely, it is very important to inform the study team should you experience any significant changes, good or bad, while participating in the study.

By participating in a clinical research study, you are helping advance medical knowledge. This knowledge may lead to approval of a new treatment that could help you and others in the future. Study related medical care and study medication are provided at no cost, and there may be reimbursement for time and travel.

Participation is voluntary. You can decide to withdraw from the study at any time, without reason, even after you’ve signed the informed consent. The study doctor may still need to check your health for a period of time after you stop the study, but you will no longer be obligated to participate or to carry out any of the required tasks associated with the study.

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