ClinicalTrials.gg
CompletedNCT05056935Updated Sep 27, 2021

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

A Phase 2 interventional study of LB1148 and Placebo in Ileus, sponsored by Newsoara Biopharma Co., Ltd.. Completed at 6 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-27.

Sponsored by Newsoara Biopharma Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jul 2019, registered Sep 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ileus

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03

In context

Ileus

167 studies on the registry are indexed under Ileus; 23 are open to participants now.

This study's enrollment of 131 is above the median of 90 across 138 interventional studies indexed under Ileus.

Browse Ileus studies →

Lead sponsor

Newsoara Biopharma Co., Ltd. is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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. (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 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 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. (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 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 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
131 participants (actual)

Study arms

  • Experimental
    LB1148

    active

    Drug: LB1148

  • Placebo comparator
    Placebo

    placebo

    Drug: Placebo

Interventions

  • DrugLB1148

    Drug pages: Tranexamic Acid · Protease Inhibitor Formulation LB1148

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

  • DrugPlacebo

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

06

What researchers measure

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.

    Time frame: within 14 days after surgery

Secondary outcomes

  1. Time to reach GI-3

    • GI-3 is defined as the toleration of solid food and either first flatus or bowel movement.

    Time frame: within 14 days after surgery

  2. Nausea Verbal Rating Scoring Scale

    • To assess the nausea and ability to tolerate food

    Time frame: within 14 days after surgery

  3. Number of days in the hospital

    • Length of Stay (number of days in the hospital, evaluated in hours) will be measured by time to * Discharge order is written, * Actual discharge, and * Standard discharge criteria

    Time frame: within 14 days after surgery

07

Study locations

6 sites
  • The Sixth Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China
  • General Hospital of Xuzhou Mining Group
    Xuzhou, Jiangsu, China
  • Affiliated Hospital of Jiangsu University
    Zhenjiang, Jiangsu, China
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong, China
  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai, China
  • Ningbo First Hospital
    Ningbo, Zhejiang, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05056935
Responsible party
Sponsor
First posted
Sep 27, 2021
Start date
Jul 9, 2019
Primary completion
Jul 22, 2020
Completion
Aug 8, 2020
Last update
Sep 27, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Tranexamic Acid · Protease Inhibitor Formulation LB1148

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