A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection

Ileus Clinical Trial

— INTEGRITY  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05470387
• Other study ID #: PBI-POI-301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 28, 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2022
• Source: Palisade Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Ileus
• Intestinal Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Site 321	Baltimore	Maryland
United States	Site 359	Bridgeport	Connecticut
United States	Site 324	Burlington	Massachusetts
United States	Site 318	Chapel Hill	North Carolina
United States	Site 351	Clearwater	Florida
United States	Site 313	Columbus	Ohio
United States	Site 320	Dallas	Texas
United States	Site 355	Grand Rapids	Michigan
United States	Site 319	Houston	Texas
United States	Site 357	Iowa City	Iowa
United States	Site 358	Jacksonville	Florida
United States	Site 354	La Jolla	California
United States	Site 331	Miami	Florida
United States	Site 315	Mobile	Alabama
United States	Site 317	New York	New York
United States	Site 356	New York	New York
United States	Site 329	Orange	California
United States	Site 353	Providence	Rhode Island
United States	Site 325	Rochester	Minnesota
United States	Site 352	Saint Louis	Missouri
United States	Site 326	Salt Lake City	Utah
United States	Site 350	San Diego	California
United States	Site 312	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Palisade Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to return of gastrointestinal function	The later of the times in hours from placement of the last skin staple or suture to the time of toleration of solid food (defined as the time a subject finished a meal that required chewing and experienced no significant nausea/vomiting for 4 hours after the solid meal) and the first bowel movement, up to 14 days post-surgery	From surgical procedure up to 14 days in hospital
Secondary	Time to first bowel movement	Time in hours from placement of the last skin staple or suture to the time of first bowel movement	From surgical procedure up to 14 days in hospital
Secondary	Time subject is ready for discharge	Time subject is ready for discharge, defined as the time from the end of surgery to the time the subject is ready for hospital discharge solely based on the recovery of GI function, as determined by the surgeon	From surgical procedure up to 14 days in hospital
Secondary	Time discharge order written	Time discharge order written, defined as the time from the end of surgery to the time that the hospital discharge order is written	From surgical procedure up to 14 days in hospital
Secondary	Time of actual discharge	Time of actual discharge, defined as the time from the end of surgery to the time the subject is actually discharged from the hospital	From surgical procedure up to 14 days in hospital