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Study Summary
This trial tests a new medicine to treat colon ulcers in adults, looking at safety, effectiveness, and how it's processed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with moderate to severe ulcerative colitis for at least 3 months.I have a history of certain colon conditions or cancer.I had bowel surgery less than 6 months ago.My disease affects areas more than 15 cm from the start of my large intestine.I have severe colon inflammation, liver bile duct inflammation, or abnormal growths in my colon.I weigh more than 88.2 pounds.I have tried at least one standard treatment for UC without success.I have not had any serious infections in the last 6 months.I haven't had major surgery or significant injury in the last 4 weeks and don't need or plan any surgery during the study.
- Group 1: Treatment Group 1
- Group 2: Treatment Group 2
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Treatment Group 1 received the FDA's stamp of approval?
"Treatment Group 1's safety level was determined to be a 1 due to the limited clinical evidence gathered during Phase I of this trial."
How many individuals have been included in the research so far?
"This research endeavours to recruit 27 suitable individuals that meet the criteria for inclusion. Locations where this study is being conducted include IHS Health Research in Kissimmee, Florida and Orlando Diagnostic Center (CXR Only) in Columbia, Maryland."
Are individuals above the age of majority able to participate in this scientific experiment?
"The current study is seeking patients between the ages of 18 and 75. There are 70 studies that cater to participants under 18, while 347 trials target individuals over 65 years old."
Could I potentially become a participant in this research project?
"This clinical trial seeks to enrol 27 individuals with ulcerative colitis, between the ages of 18 and 75. In order to qualify for this study, participants must demonstrate an active form of the disease that extends beyond 15 cm from the anal verge at screening endoscopy; have had inadequate response or intolerance to a prior conventional remedy; weigh more than 40 kg (88.2 lbs); be diagnosed with moderate-to-severe UC no less than 3 months before baseline; and receive a score ranging from 5 - 9 on the modified Mayo Score, which includes an endoscopy subscore equal to or greater than 2."
Has sign-up for this clinical experiment opened yet?
"According to the clinicaltrials.gov website, this medical trial is still recruiting patients for participation. This experiment was posted on November 7th 2022 and has been updated as late as November 17th of that same year."
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