Clinical trial NCT05470387: A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of LB1148 in Accelerating the Time to Return of Bowel Function in Subjects Undergoing Planned Bowel Resection (INTEGRITY)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ileus
Gastro-Intestinal Disorder
Keywords: post operative ileus
return of bowel function
return of gastrointestinal function
enterotomy
colon surgery
colorectal surgery
intestinal surgery
Lead sponsor: Palisade Bio
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.

Detailed description: This will be a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the safety and efficacy of LB1148 in return to bowel function for subjects undergoing planned bowel resection.

Eligibility criteria: Inclusion Criteria:

Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:

1. Adults age 18 to 80 years, inclusive.
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:

Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:

1. History of total colectomy.
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.

Primary outcomes:
measure: Time to Return of Gastrointestinal Function
timeFrame: From surgical procedure up to 14 days in hospital
Secondary outcomes:
measure: Time to First Bowel Movement
timeFrame: From surgical procedure up to 14 days in hospital
measure: Time Subject is Ready for Discharge
timeFrame: From surgical procedure up to 14 days in hospital
measure: Time Discharge Order Written
timeFrame: From surgical procedure up to 14 days in hospital
measure: Time of Actual Discharge
timeFrame: From surgical procedure up to 14 days in hospital
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Site 315
state: Alabama
city: La Jolla
country: United States
facility: Site 354
state: California
city: Orange
country: United States
facility: Site 329
state: California
city: San Diego
country: United States
facility: Site 350
state: California
city: Torrance
country: United States
facility: Site 312
state: California
city: Bridgeport
country: United States
facility: Site 359
state: Connecticut
city: Clearwater
country: United States
facility: Site 351
state: Florida
city: Jacksonville
country: United States
facility: Site 358
state: Florida
city: Miami
country: United States
facility: Site 331
state: Florida
city: Iowa City
country: United States
facility: Site 357
state: Iowa
city: Baltimore
country: United States
facility: Site 321
state: Maryland
city: Burlington
country: United States
facility: Site 324
state: Massachusetts
city: Grand Rapids
country: United States
facility: Site 355
state: Michigan
city: Rochester
country: United States
facility: Site 325
state: Minnesota
city: Saint Louis
country: United States
facility: Site 352
state: Missouri
city: New York
country: United States
facility: Site 317
state: New York
city: New York
country: United States
facility: Site 356
state: New York
city: Chapel Hill
country: United States
facility: Site 318
state: North Carolina
city: Columbus
country: United States
facility: Site 313
state: Ohio
city: Providence
country: United States
facility: Site 353
state: Rhode Island
city: Dallas
country: United States
facility: Site 320
state: Texas
city: Houston
country: United States
facility: Site 319
state: Texas
city: Salt Lake City
country: United States
facility: Site 326
state: Utah
Study officials:
affiliation: CMO
name: Mitch Jones, MD
role: STUDY_DIRECTOR
References: