Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus

NCT05056935 | Completed Phase 2

• 1 other identifier: LBS-POI-201
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 6

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.

Conditions

Ileus

Outcome Measures

Primary Outcomes (1)

• Time to reach GI-2

  • GI-2 is defined as the toleration of solid food and first bowel movement. * Ability to tolerate a solid oral diet is defined as the time from the end of surgery (the time of last skin staple or suture is placed by surgeon) to the time a patient finishes first solid meal that requires chewing and no significant nausea or vomiting for 4 hours after solid meal). * First bowel movement is defined as the time from the end of surgery to the first passage of stool.

  within 14 days after surgery

Secondary Outcomes (3)

• Time to reach GI-3

  within 14 days after surgery

• Nausea Verbal Rating Scoring Scale

  within 14 days after surgery

• Number of days in the hospital

  within 14 days after surgery

Study Arms (2)

LB1148

EXPERIMENTAL

active

Drug: LB1148

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

LB1148 DRUG

A total of 700 mL of LB1148 will be administered orally as a split dose before surgery.

LB1148

Placebo DRUG

A total of 700 mL of placebo will be administered orally as a split dose before surgery.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \<18 or \>80 years of age.
• Requires emergency bowel surgery.
• 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.
• American Society of Anesthesiologists (ASA) Class 4 or 5.
• Insulin dependent diabetes mellitus.
• Known inability to take the study drug orally (i.e. complete small bowel obstruction).
• Has contraindications or potential risk factors to taking tranexamic acid (TXA). These include subjects with:
• Known sensitivity to tranexamic acid (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, or
• Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
• 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.

Sponsors & Collaborators

• Newsoara Biopharma Co., Ltd.: lead

Study Sites (6)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

General Hospital of Xuzhou Mining Group

Xuzhou, Jiangsu, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Ningbo First Hospital

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 27, 2021
• Study Start: July 9, 2019
• Primary Completion: July 22, 2020
• Study Completion: August 8, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)