ClinicalTrials.gg
CompletedNCT02836470PROFILEUpdated Jun 21, 2024Results posted

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

A Phase 2 interventional study of LB1148 and Placebo in Ileus and Post-Operative Adhesions, sponsored by Palisade Bio. Completed at 28 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Palisade Bio · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
112
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 post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection.

Read the 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.

02

Conditions studied

  • Ileus
  • Post-Operative Adhesions

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Keywords

  • Post-operative Ileus
  • Post-Operative Abdominal Adhesions
  • Return of Gastrointestinal Function
  • Anastomosis
  • Enterotomy
  • Enterostomy
  • Colorectal Surgery
  • Intestines Surgery
03

In context

Ileus

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

This study's enrollment of 112 is above the median of 90 across 138 interventional studies indexed under Ileus.

Browse Ileus studies →

Lead sponsor

Palisade Bio is the lead sponsor of 5 studies on the registry; 1 is 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

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 .

Exclusion criteria

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. (ASA) Class 4 or 5.
  5. Known inability to take the study drug orally (i.e. complete small bowel obstruction).
  6. Has 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 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 therapy within 4 weeks prior to Randomization
  14. 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.
  15. Known history of radiation enteritis.
Terms in these criteria, in plain language(6)

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.

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
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
112 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 drug product will be administered orally as a split dose before surgery.

    Also known as: Active

  • 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. Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo

    Extent and severity of intra-abd. adhesions will be determined by the surgeon using the "Intra-Abdominal Adhesion Extent and Severity Assessment Worksheet" with a min. value of zero (0) (better) and a max. value of one hundred and eight (108) (worse). And which records four (4) Sub scores for nine (9) abd. regions which are all summed to make the Total Extent and severity score. Sub scores include: 1) Abd. Wall to Bowel Extent Score (0-3); 2) Abd. Wall to Bowl Severity Score (0-3); Bowel to Bowel (or Viscera) Extent Score (0-3); Bowel to Bowel (or Viscera) Severity Score (0-3); The nine (9) Abd. Regions include: Right upper; Epigastrium; Left upper; Left flank; Left lower; Pelvis; Right lower; Right flank; and Central. Each Sub score is scored with a min. value of zero (0) (better) and a max. value of three (3) (worse); 0=no adhesion; 1=min. (\<1/3 of the site is covered); 2=mod. (1/3 to 2/3 of the site is covered); 3=extensive (\>2/3 of the site is covered).

    Time frame: up to 8 months from the index surgery

07

Results

Posted Jun 21, 2024

Participant flow

Participant flow — Overall Study
MilestoneLB1148Placebo
Started5755
Completed5249
Not completed56

Outcome measures

PrimaryChange From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo

Extent and severity of intra-abd. adhesions will be determined by the surgeon using the "Intra-Abdominal Adhesion Extent and Severity Assessment Worksheet" with a min. value of zero (0) (better) and a max. value of one hundred and eight (108) (worse). And which records four (4) Sub scores for nine (9) abd. regions which are all summed to make the Total Extent and severity score. Sub scores include: 1) Abd. Wall to Bowel Extent Score (0-3); 2) Abd. Wall to Bowl Severity Score (0-3); Bowel to Bowel (or Viscera) Extent Score (0-3); Bowel to Bowel (or Viscera) Severity Score (0-3); The nine (9) Abd. Regions include: Right upper; Epigastrium; Left upper; Left flank; Left lower; Pelvis; Right lower; Right flank; and Central. Each Sub score is scored with a min. value of zero (0) (better) and a max. value of three (3) (worse); 0=no adhesion; 1=min. (\<1/3 of the site is covered); 2=mod. (1/3 to 2/3 of the site is covered); 3=extensive (\>2/3 of the site is covered).

Time frame:
up to 8 months from the index surgery
Reported as:
Mean · total extent and severity scores
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo
total extent and severity scoresLB1148Placebo
Minimally Invasive Approach20.3 ± 23.774.3 ± 5.87
Laparotomy Approach4.0 ± NA8.5 ± 9.19

Adverse events

Collected over Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LB11482/57 (3.5%)16/57 (28.1%)38/57 (66.7%)
Placebo0/55 (0%)14/55 (25.5%)40/55 (72.7%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventLB1148Placebo
Post operative ileusInjury, poisoning and procedural complications2/576/55
pyrexiaGeneral disorders0/572/55
sepsisInfections and infestations0/572/55
acute kidney injuryRenal and urinary disorders0/572/55
gastroesophageal reflux diseaseGastrointestinal disorders2/570/55
small intestinal obstructionGastrointestinal disorders2/570/55
pulmonary embolismRespiratory, thoracic and mediastinal disorders2/570/55
abdominal sepsisInfections and infestations0/571/55
septic shockInfections and infestations0/571/55
wound infectionInfections and infestations0/571/55
Most frequent other events
Showing 10 of 13
Most frequent other events
EventLB1148Placebo
nauseaGastrointestinal disorders12/5712/55
Postoperative ileusInjury, poisoning and procedural complications4/578/55
VomitingGastrointestinal disorders5/576/55
Procedural painInjury, poisoning and procedural complications6/574/55
HypokalaemiaMetabolism and nutrition disorders5/571/55
Urinary retentionRenal and urinary disorders5/571/55
Gastrooesophageal reflux diseaseGastrointestinal disorders4/570/55
Acute kidney injuryRenal and urinary disorders1/573/55
DyspepsiaGastrointestinal disorders0/573/55
pyrexiaGeneral disorders2/573/55

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)LB1148PlaceboTotal
<=18 years000
Between 18 and 65 years363672
>=65 years211940
Age, Continuous
Age, Continuous(years)LB1148PlaceboTotal
Mean59.4 ± 11.5655.9 ± 13.9457.6 ± 12.85
Sex: Female, Male
Sex: Female, Male(Participants)LB1148PlaceboTotal
Female242448
Male333164
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)LB1148PlaceboTotal
White/Caucasian5249101
Black336
Asian011
American Indian000
Native Hawaiian or Pacific Islander101
Other123
Region of Enrollment
Region of Enrollment(participants)LB1148PlaceboTotal
United States5755112
08

Study locations

28 sites
  • Site 315
    Mobile, Alabama 36617, United States
  • Site 307
    Yuma, Arizona 85364, United States
  • Site 329
    Irvine, California 92868, United States
  • Site 310
    Pasadena, California 91105, United States
  • Site 302
    Sylmar, California 91342, United States
  • Site 312
    Torrance, California 90502, United States
  • Site 306
    Clearwater, Florida 33756, United States
  • Site 303
    Miami, Florida 33125, United States
  • Site 331
    Miami, Florida 33126, United States
  • Site 305
    Miami, Florida 33142, United States
  • Site 308
    Orlando, Florida 32804, United States
  • Site 328
    Louisville, Kentucky 40202, United States
  • Site 321
    Baltimore, Maryland 21237, United States
  • Site 324
    Burlington, Massachusetts 01850, United States
  • Site 325
    Rochester, Minnesota 55905, United States
  • Site 317
    New York, New York 10029, United States
  • Site 323
    New York, New York 10075, United States
  • Site 318
    Chapel Hill, North Carolina 27599, United States
  • Site 301
    Cleveland, Ohio 44195, United States
  • Site 322
    Pittsburgh, Pennsylvania 15212, United States
  • Site 330
    Wynnewood, Pennsylvania 19096, United States
  • Site 327
    Charleston, South Carolina 29425, United States
  • Site 320
    Dallas, Texas 75390, United States
  • Site 316
    Fort Worth, Texas 76104, United States
  • Site 311
    Houston, Texas 77024, United States
  • Site 319
    Houston, Texas 77030, United States
  • Sie 309
    Houston, Texas 77089, United States
  • Site 326
    Salt Lake City, Utah 84132, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2019 to primary completion in Sep 2023, 47 months.

Results were first posted in Jun 2024, 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2016
First posted
Jul 19, 2016
StartActual
Oct 1, 2019
Primary completionActual
Sep 6, 2023
CompletionActual
Sep 8, 2023
Results first posted
Jun 21, 2024
Last update
Jun 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02836470
Lead sponsor
Palisade Bio
Responsible party
Sponsor
First posted
Jul 19, 2016
Start date
Oct 1, 2019
Primary completion
Sep 6, 2023
Completion
Sep 8, 2023
Results posted
Jun 21, 2024
Last update
Jun 21, 2024

Study contacts

Mitch Jones, MD
study director · CMO

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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

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