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LB1148 for Gastrointestinal Disorders(INTEGRITY Trial)
INTEGRITY Trial Summary
This trial will test a new drug to see if it is safe and effective in people who are having surgery to remove part of their bowel.
- Intestinal Obstruction
- Gastrointestinal Disorder
INTEGRITY Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
INTEGRITY Trial Design
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Who is running the clinical trial?
- You have a history of seizures.You are unable to swallow pills or eat solid food.You have a history of a condition called radiation enteritis, which is a complication from previous radiation treatment.
- Group 1: Placebo
- Group 2: LB1148
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is it legal to market and sell LB1148 in the United States?
"We believe that LB1148 is safe to use (3 out of 3 on our scale) because it has gone through Phase 3 trials. This means that not only is there some evidence that it is effective, but also that it has been tested multiple times for safety."
Are there any vacancies for clinical trial participants?
"That is right, the clinicaltrials.gov website has the most recent information on this trial's status. According to the site, this study was first posted on 6/28/2022 and is still recruiting participants. There are 23 different hospitals or clinics where patients can enroll, and the goal is to have 600 people total in the trial."
Is this clinical trial taking place only in the United States or are there other countries involved as well?
"23 medical facilities across the country are recruiting patients for this study. Site 354 in La Jolla, Site 318 in Chapel Hill, and Site 353 in Providence are a few of the participating locations."
If a patient is 55 or older, are they still able to participate in this research?
"This trial, which has 160 other similar studies for patients over 65 and 50 for those under 18, is looking for patients aged 18 to 80."
Could you please inform me as to how many individuals are enrolled in this clinical trial?
"Yes, according to the latest information on clinicaltrials.gov, this study is looking for 600 subjects at 23 research sites. The listing was first put up on 6/28/2022 and has since been updated on 10/20/2022."
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