A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
NCT ID: NCT05470387
Last Updated: 2024-06-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
23 participants
INTERVENTIONAL
2022-06-28
2023-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LB1148
LB1148
A total of 700 mL of drug product will be administered orally as a split dose before surgery.
Placebo
Placebo
A total of 700 mL of placebo will be administered orally as a split dose before surgery.
Interventions
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LB1148
A total of 700 mL of drug product will be administered orally as a split dose before surgery.
Placebo
A total of 700 mL of placebo will be administered orally as a split dose before surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Scheduled to undergo a planned (non-emergent) bowel resection via minimally invasive technique or laparotomy. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elective indication.
3. Willing to perform and comply with all study procedures including, being hospitalized until achieving GI-2 and responding to telephone follow-up visits as scheduled.
4. Willing and able to provide written informed consent.
Exclusion Criteria
2. Has a preexisting ostomy.
3. History of radiation enteritis.
4. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2.
5. History of seizure disorder.
6. History of myeloproliferative disorders.
7. American Society of Anesthesiologists (ASA) Class IV or V.
8. Inability to take IP orally or consume solid food.
9. Planned treatment with alvimopan (Entereg®) during hospitalization period
10. Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
11. Men and women of child bearing potential (WOCBP) who are unwilling to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods (but not combination hormonal methods), intrauterine device, or use of spermicide combined with a barrier method (e.g., condom, diaphragm) for 28 days before Day 1 and through Day 30.
12. Women who will not agree to stop combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch or vaginal ring) during the 7 day period prior to Surgery (Study Day 2) through the 7 day period following surgery (Study Days 3 through 9).
13. Has contraindications or potential risk factors to taking TXA. These include subjects with:
* Known sensitivity to TXA
* Recent craniotomy (past 30 days)
* Active cerebrovascular bleed
* Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome)
* Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction
14. Receipt of any investigational drug within 28 days or 5 half-lives prior to Day 1.
15. Any other condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.
18 Years
80 Years
ALL
No
Sponsors
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Palisade Bio
INDUSTRY
Responsible Party
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Principal Investigators
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Mitch Jones, MD
Role: STUDY_DIRECTOR
CMO
Locations
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Site 315
Mobile, Alabama, United States
Site 354
La Jolla, California, United States
Site 329
Orange, California, United States
Site 350
San Diego, California, United States
Site 312
Torrance, California, United States
Site 359
Bridgeport, Connecticut, United States
Site 351
Clearwater, Florida, United States
Site 358
Jacksonville, Florida, United States
Site 331
Miami, Florida, United States
Site 357
Iowa City, Iowa, United States
Site 321
Baltimore, Maryland, United States
Site 324
Burlington, Massachusetts, United States
Site 355
Grand Rapids, Michigan, United States
Site 325
Rochester, Minnesota, United States
Site 352
St Louis, Missouri, United States
Site 317
New York, New York, United States
Site 356
New York, New York, United States
Site 318
Chapel Hill, North Carolina, United States
Site 313
Columbus, Ohio, United States
Site 353
Providence, Rhode Island, United States
Site 320
Dallas, Texas, United States
Site 319
Houston, Texas, United States
Site 326
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PBI-POI-301
Identifier Type: -
Identifier Source: org_study_id
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