We are looking for adults who have certain digestive issues or have been diagnosed with gastroparesis to participate in a clinical research study.
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.
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.
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.
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:
A Phase I study includes a small number of participants and can take several months to complete. These individuals are tested to evaluate the safety, dosage and slide effects of a drug.
A Phase II study can include up to several hundred participants with the disease that the study drug will potentially treat. Researchers want to determine the effective dosage range while also monitoring for safety of the drug. A Phase II study can last several months to years.
In a Phase III study the number of participants generally ranges from several hundred to several thousand. These volunteers are usually randomly assigned to either a treatment group or a control group. Monitoring side-effects is the primary focus of a Phase III study. Participants are tested and asked to share their reactions to the study drug they receive. Researchers monitor its effectiveness and compare this information with existing treatments. A Phase III study can last several months to years.
After a drug has been approved and is available to US consumers, then a Phase IV study or a “post-marketing study” can be launched. Participants in this study are taking the marketed drug and agree to be surveyed about efficacy and side effects over long periods of time.