At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 112 enrolled
Drug / intervention
LB1148 +1 moredrug
Likely dose
LB1148 700 mL total, administered orally as split dose before surgeryAI-extracted
Key inclusion· 3
- ✓Scheduled for elective (non-emergent) bowel resection with planned stoma creation via laparotomy or minimally invasive technique
- ✓Planned stoma takedown or other planned abdominal surgery within 8 months of initial surgery
- ✓Willing and able to comply with all study procedures including second surgery for stoma takedown or other abdominal surgery
Key exclusion· 20
- ✕Age <18 or >80 years
- ✕Requires emergency bowel surgery
- ✕Prior abdominal surgery for inflammatory bowel disease (IBD, Crohn's Disease, ulcerative colitis)
- ✕ASA Class 4 or 5
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating LB1148 and Placebo for Ileus and Post-Operative Adhesions. Completed, enrolled 112 participants across 28 sites.
Detailed Summary
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIleus, Post-Operative Adhesions
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartOct 2019
Primary CompletionSep 2023
Study CompletionSep 2023
TodayJul 2026
First PostedJul 19, 2016
Enrollment StartOct 1, 2019
Primary CompletionSep 6, 2023
Study CompletionSep 8, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.0 years ago
Interventions
LB1148drug
A total of 700 mL of drug product will be administered orally as a split dose before surgery.
Placebodrug
A total of 700 mL of placebo will be administered orally as a split dose before surgery.