A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection (PROFILE)
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|ClinicalTrials.gov Identifier: NCT02836470|
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : September 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Ileus Post-Operative Adhesions||Drug: LB1148 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Post-Operative Ileus and Intra-Abdominal Adhesions in Subjects Undergoing Elective Bowel Resection|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
A total of 700 mL of drug product will be administered orally as a split dose before surgery.
Other Name: Active
Placebo Comparator: Placebo
A total of 700 mL of placebo will be administered orally as a split dose before surgery.
- Change from baseline in extent and severity of intra-abdominal adhesions among subjects treated with LB1148 or placebo [ Time Frame: up to 8 months from the index surgery ]Extent and severity of intra-abdominal adhesions will be determined by the surgeon using the Intra-Abdominal Adhesion Extent and Severity Assessment Worksheet
- Time from surgical closure to resolution or appearance, as appropriate, of 1 or more of the components common to GI dysfunction following elective bowel resection with or without a planned stoma [ Time Frame: From surgical closure up to 14 days in hospital ]Compare time from surgical closure to resolution or appearance, as appropriate, of 1 or more of the components common to gastrointestinal (GI) dysfunction following elective bowel resection with a planned stoma.
- Time to return of gastrointestinal function as defined by achieving GI2 [ Time Frame: From surgical closure up to 14 days in hospital ]GI2 is a composite endpoint defined as the time from the end of surgery to the time of recovery of the upper GI tract (toleration of solid food) and the time to recovery of the lower GI tract (first bowel movement).
- Time to Achieve GI-3 [ Time Frame: From surgical closure up to 14 days in hospital ]GI3 is defined as the toleration of solid food and either first flatus or bowel movement
- Time to resolution of post-operative ileus [ Time Frame: From surgical closure up to 14 days in hospital ]Compare number of hours to resolution of POI.
- Hospital length of stay [ Time Frame: From surgical closure up to 14 days in hospital ]Compare hospital length of stay (LOS, recorded in hours) through Discharge or Day 14 (whichever comes first).
- Incidence of intra-abdominal adhesions [ Time Frame: up to 8 months from the index surgery ]Compare the incidence of intra-abdominal adhesions following the second surgery among subjects treated with LB1148 or placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836470
|Contact: Nick McCoyfirstname.lastname@example.org|
|Study Director:||Michael J Dawson, MD||Palisa|