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Copyright © 2021 Pinnacle GI Partners | All Rights Reserved
Providing Premium Support To Our GI Practice Partners
So You Can Spend More Time Caring For Your Patients
Copyright © 2021 Pinnacle GI Partners | All Rights Reserved
Achalasia is a rare disorder that makes it difficult for food and liquid to pass from the esophagus to the stomach. Achalasia occurs when nerves in the esophagus become damaged. The esophagus then becomes paralyzed and dilated over time and eventually loses the ability to squeeze (peristalsis) food down into the stomach. Food then collects in the esophagus and at times is regurgitated into the mouth. Symptoms of achalasia are similar gastroesophageal reflux disease (GERD).
The exact cause of achalasia is poorly understood. Researchers suspect it may be caused by a loss of nerve cells in the esophagus. There are theories about what causes this, but viral infection or autoimmune responses have been suspected. Very rarely, achalasia may be caused by an inherited genetic disorder or infection.
A muscular ring at the point where the esophagus and stomach come together (lower esophageal sphincter) normally relaxes during swallowing. In people with achalasia, this muscle ring does not relax as well. The reason for this problem is damage to the nerves of the esophagus.
Achalasia is a rare disorder. It may occur at any age, but is most common in middle-aged or older adults. This problem may be inherited in some people.
Tests include:
Physical examination may show signs of anemia or malnutrition.
Tests include:
Surgical options for treating achalasia include:
The outcomes of surgery and nonsurgical treatments are similar. Sometimes more than one treatment is necessary.
A clinical research study is medical research with human volunteers to learn more about investigational drugs, bringing innovative medicines to the patients that need them. Clinical research studies help us understand safety and effectiveness of the investigational medication being researched. Volunteers in clinical research studies may be asked to attend study visits, complete study procedures, and undergo relevant tests. The U-Excel and U-Exceed studies described in this pamphlet are Phase 3 studies, where researchers need to confirm the effectiveness and safety of the investigational medication observed in prior Phase 2 studies and monitor its side effects in a large group of study participants. If you decide to participate we’ll closely monitor your health and protect your privacy.
Volunteers for clinical research have different reasons for participating, including:
You may qualify to participate if you meet the following requirements:
The investigational medication, which is an oral, once-daily pill, is a drug that is being studied in patients with inflammatory bowel disease and other inflammatory diseases. It works by blocking the actions of a protein that is involved in the immune response and also in the development of
chronic inflammation. In this study, the investigational medication will be compared to a placebo. A placebo looks like the investigational medication but does not have any investigational medication in it. Placebos help researchers understand if the investigational medication is effective in treating the disease. You should ask the study staff any questions you have about the investigational medication, including potential side effects and standard treatments that are available for Crohn’s disease.
Physical examination may show signs of anemia or malnutrition.
Tests include:
Your ability to participate involves a few different steps to determine if you are a good candidate for the study:
Study participants are assigned to receive the investigational medication (active drug) or placebo at random. There is a 67% chance participants will recieve active drug and a 33% chance they will recieve placebo. Neither you nor the study doctor and staff will know what treatment you are assigned to receive. While you may initially receive placebo, at Week 12 your response to your study treatment will be evaluated and may be adjusted if the treatment has not been working for you. If you stay in the study for Weeks 12–24, you will receive the active drug. You should talk to your personal doctor and the study doctor about which of your regular Crohn’s treatments you can continue to take while you participate in the study.
Once you enter the study treatment phase, visits are approximately every four weeks and will involve procedures like blood tests, stool samples, and receiving the investigational medication or placebo.
At every study visit, the study staff will perform certain routine checks to monitor your health and safety, administer your study treatment, and check your Crohn’s disease symptoms.