Clinical trial NCT05056935: Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus
Official title: A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus in Subjects Undergoing Elective Bowel Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ileus
Lead sponsor: Newsoara Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 131
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 return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing elective bowel resection.


Eligibility criteria: Inclusion Criteria:

1. Scheduled to undergo an elective (non-emergent) bowel resection with or without 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. 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:

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. Insulin dependent diabetes mellitus.
6. Known inability to take the study drug orally (i.e. complete small bowel obstruction).
7. Has contraindications or potential risk factors to taking tranexamic acid (TXA). These include subjects with:

   1. Known sensitivity to tranexamic acid (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).
8. Known allergic reaction to polyethylene glycol (PEG) 4000 powder, combination formulation of polyethylene glycol (PEG) and electrolyte powder, polyethylene glycol (PEG) 3350 solution and glucose formulation.
9. Has the following risk factors for thromboembolic disease:

   1. Known medical history of congenital or acquired thrombophilia such as, but not limited to patients with:

      * Sickle cell disease;
      * Nephrotic syndrome;
      * Factor V Leiden;
      * Prothrombin gene mutation;
      * Protein C or S deficiency;
      * Antithrombin III deficiency;
      * Antiphospholipid syndrome.
   2. Stage IV malignant neoplasm;
   3. Neurologic paresis, partial paralysis, or paralysis;
   4. Pacemaker;
   5. History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or rental venous/arterial occlusion;
10. History of or current seizure disorder.
11. Patients with myeloproliferative disorders.
12. Body Mass Index (BMI) \>40.
13. 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.
14. Planned treatment with alvimopan (Entereg®) during study participation period.
15. Received any other investigational therapy within 4 weeks prior to Randomization
16. Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
17. 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.
18. Known history of radiation enteritis.

Primary outcomes:
measure: Time to reach GI-2
timeFrame: within 14 days after surgery
Secondary outcomes:
measure: Time to reach GI-3
timeFrame: within 14 days after surgery
measure: Nausea Verbal Rating Scoring Scale
timeFrame: within 14 days after surgery
measure: Number of days in the hospital
timeFrame: within 14 days after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Xuzhou
country: China
facility: General Hospital of Xuzhou Mining Group
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
References: