Like many ULCERATIVE COLITIS (UC) patients, your doctor has prescribed mesalamine to treat your UC. While mesalamine can be effective against UC for some patients, other UC patients continue to struggle with symptoms of their disease
To pre-qualify for this study, you must be:
As a result, you may be considering additional options for
long-term treatment of your UC.
One option is this research study of an investigational drug that is taken along with your mesalamine prescription. In this study, local doctors want to evaluate an investigational drug called
LT-02 as an add-on treatment for UC.
The investigational drug, which is soy-based, is a delayed-release drug that is in the form of pellets and taken twice a day before a meal.
Doctors want to compare LT-02 with placebo, which looks like the investigational drug, but contains no active medication. The results of this study will provide more information about the investigational drug and whether it could one day be used as an add-on treatment with current UC medications.
Who is eligible to participate in this study?
All study-related visits, tests, and drugs will be provided to participants at no cost. In addition, compensation for study-related time and travel may be provided.
If you do not meet these eligibility criteria right now, but do so at a future date, please contact the study coordinator about your eligibility, using the telephone number on the back of this brochure.
Before you can participate in the study, you must first be screened for eligibility. If you are eligible, and you agree to participate, you will be randomly assigned to one of two study groups.
One group will receive the investigational drug and one group will receive placebo. You have a 67% (2/3) chance of receiving the investigational drug and a 33% (1/3) chance of receiving placebo.
You, the study doctor, and the study staff will not know which study drug (investigational or placebo) you are receiving. This is to prevent any opinions about the study drugs from affecting the results of the study. However, in the event of an emergency, this information will be provided.
No matter which study drug you receive, you will take it in the morning and evening 30 to 60 minutes before a meal. You may mix your study drug with water, juice, milk, or yogurt. You will take your study drug twice a day for 12 weeks.
You total study participation will last approximately 20 weeks and includes 6 study clinic visits for treatment and
follow-up. Additionally, you will receive 1 phone call from the study staff. During your study clinic visits, study doctors and staff members will evaluate your health and progress through various tests and assessments. Some of these include, but are not limited to:
You will also be given an electronic diary and asked to record your daily UC symptoms and study drug dosing details. This diary must be completed every day in order for you to remain in the study.
If you complete the study, you may have the option to participate in an extension study in which all patients will receive the investigational drug.
As with any medical research study, your study drug may not help your UC. The investigational medication has been studied before and most patients in those studies tolerated it well. However, it is possible that you could experience a side effect while in this study.
You will be closely monitored throughout this study. Researchers for this study are required to follow the study protocol, which explains all study procedures in detail. An independent review board responsible for patient safety has reviewed these procedures and approved this protocol.
What if I have questions?