Clinical trial NCT02836470: A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ileus
Post-Operative Adhesions
Keywords: Post-operative Ileus
Post-Operative Abdominal Adhesions
Return of Gastrointestinal Function
Anastomosis
Enterotomy
Enterostomy
Colorectal Surgery
Intestines Surgery
Lead sponsor: Palisade Bio
Sponsor class: INDUSTRY
First posted: 2016-07-19
Enrollment: 112
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 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.

Detailed description: This will be a multicenter, randomized, double-blind, parallel, placebo-controlled, proof-of-concept, adaptive design, Phase 2 study to evaluate LB1148 for return of gastrointestinal function and reduction of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection surgery with or without a planned stoma.

Eligibility criteria: Inclusion Criteria:

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

1. Scheduled to undergo an elective (non-emergent) bowel resection with a planned stoma via laparotomy or minimally invasive technique. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elected indication.
2. Planned stoma takedown or other planned abdominal surgery within 8 months of the initial surgery.
3. Willing to perform and comply with all study procedures including attending clinic visit as scheduled and completion of a second surgery for stoma takedown or other abdominal surgery and to determine the presence of intra-abdominal adhesions.
4. Has been informed of the nature of the study (either the subject or their legal representative), agrees to its provisions, and has provided 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. \<18 or \>80 years of age.
2. Requires emergency bowel surgery.
3. Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's Disease, or ulcerative colitis.

   Note: This does not apply to previous surgery such as hernia repair unrelated to IBD.
4. American Society of Anesthesiologists (ASA) Class 4 or 5.
5. Known inability to take the study drug orally (i.e. complete small bowel obstruction).
6. Has contraindications or potential risk factors to taking TXA. These include subjects with:

   1. Known sensitivity to TXA;
   2. Recent craniotomy (past 30 days);
   3. Active cerebrovascular bleed;
   4. Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome);
   5. Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction, or
   6. Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
7. Has peritoneal carcinomatosis
8. History of or current seizure disorder.
9. Patients with myeloproliferative disorders.
10. Any other condition that, in the opinion of the Investigator, would preclude the subject from being an appropriate candidate for the study, including severe renal or hepatic impairment.
11. Planned treatment with alvimopan (Entereg®) during study participation period.
12. Planned use of 4% icodextrin (Adept®) or SEPRAFILM during the first surgery.
13. Received any other investigational therapy within 4 weeks prior to Randomization
14. Female subjects of childbearing potential with a positive urine or serum pregnancy test or who are not taking (or not willing to take) acceptable birth control measures (abstinence, intrauterine devices, contraceptive implants or barrier methods) through Day 30. Additionally, those women who are lactating and insist on breast feeding within 5 days of the last dose of study drug.
15. Known history of radiation enteritis.

Primary outcomes:
measure: Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo
timeFrame: up to 8 months from the index surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Site 315
state: Alabama
city: Yuma
country: United States
facility: Site 307
state: Arizona
city: Irvine
country: United States
facility: Site 329
state: California
city: Pasadena
country: United States
facility: Site 310
state: California
city: Sylmar
country: United States
facility: Site 302
state: California
city: Torrance
country: United States
facility: Site 312
state: California
city: Clearwater
country: United States
facility: Site 306
state: Florida
city: Miami
country: United States
facility: Site 303
state: Florida
city: Miami
country: United States
facility: Site 331
state: Florida
city: Miami
country: United States
facility: Site 305
state: Florida
city: Orlando
country: United States
facility: Site 308
state: Florida
city: Louisville
country: United States
facility: Site 328
state: Kentucky
city: Baltimore
country: United States
facility: Site 321
state: Maryland
city: Burlington
country: United States
facility: Site 324
state: Massachusetts
city: Rochester
country: United States
facility: Site 325
state: Minnesota
city: New York
country: United States
facility: Site 317
state: New York
city: New York
country: United States
facility: Site 323
state: New York
city: Chapel Hill
country: United States
facility: Site 318
state: North Carolina
city: Cleveland
country: United States
facility: Site 301
state: Ohio
city: Pittsburgh
country: United States
facility: Site 322
state: Pennsylvania
city: Wynnewood
country: United States
facility: Site 330
state: Pennsylvania
city: Charleston
country: United States
facility: Site 327
state: South Carolina
city: Dallas
country: United States
facility: Site 320
state: Texas
city: Fort Worth
country: United States
facility: Site 316
state: Texas
city: Houston
country: United States
facility: Site 311
state: Texas
city: Houston
country: United States
facility: Site 319
state: Texas
city: Houston
country: United States
facility: Sie 309
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: