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
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.
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.
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 →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.
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.
Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:
Exclusion Criteria:
Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:
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.
Has or potential risk factors to taking TXA. These include subjects with:
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.
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active
Drug: LB1148
Placebo
Drug: Placebo
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
A total of 700 mL of placebo will be administered orally as a split dose before surgery.
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
| Milestone | LB1148 | Placebo |
|---|---|---|
| Started | 57 | 55 |
| Completed | 52 | 49 |
| Not completed | 5 | 6 |
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).
| total extent and severity scores | LB1148 | Placebo |
|---|---|---|
| Minimally Invasive Approach | 20.3 ± 23.77 | 4.3 ± 5.87 |
| Laparotomy Approach | 4.0 ± NA | 8.5 ± 9.19 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LB1148 | 2/57 (3.5%) | 16/57 (28.1%) | 38/57 (66.7%) |
| Placebo | 0/55 (0%) | 14/55 (25.5%) | 40/55 (72.7%) |
| Event | LB1148 | Placebo |
|---|---|---|
| Post operative ileusInjury, poisoning and procedural complications | 2/57 | 6/55 |
| pyrexiaGeneral disorders | 0/57 | 2/55 |
| sepsisInfections and infestations | 0/57 | 2/55 |
| acute kidney injuryRenal and urinary disorders | 0/57 | 2/55 |
| gastroesophageal reflux diseaseGastrointestinal disorders | 2/57 | 0/55 |
| small intestinal obstructionGastrointestinal disorders | 2/57 | 0/55 |
| pulmonary embolismRespiratory, thoracic and mediastinal disorders | 2/57 | 0/55 |
| abdominal sepsisInfections and infestations | 0/57 | 1/55 |
| septic shockInfections and infestations | 0/57 | 1/55 |
| wound infectionInfections and infestations | 0/57 | 1/55 |
| Event | LB1148 | Placebo |
|---|---|---|
| nauseaGastrointestinal disorders | 12/57 | 12/55 |
| Postoperative ileusInjury, poisoning and procedural complications | 4/57 | 8/55 |
| VomitingGastrointestinal disorders | 5/57 | 6/55 |
| Procedural painInjury, poisoning and procedural complications | 6/57 | 4/55 |
| HypokalaemiaMetabolism and nutrition disorders | 5/57 | 1/55 |
| Urinary retentionRenal and urinary disorders | 5/57 | 1/55 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 4/57 | 0/55 |
| Acute kidney injuryRenal and urinary disorders | 1/57 | 3/55 |
| DyspepsiaGastrointestinal disorders | 0/57 | 3/55 |
| pyrexiaGeneral disorders | 2/57 | 3/55 |
| Age, Categorical(Participants) | LB1148 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 36 | 36 | 72 |
| >=65 years | 21 | 19 | 40 |
| Age, Continuous(years) | LB1148 | Placebo | Total |
|---|---|---|---|
| Mean | 59.4 ± 11.56 | 55.9 ± 13.94 | 57.6 ± 12.85 |
| Sex: Female, Male(Participants) | LB1148 | Placebo | Total |
|---|---|---|---|
| Female | 24 | 24 | 48 |
| Male | 33 | 31 | 64 |
| Race/Ethnicity, Customized(participants) | LB1148 | Placebo | Total |
|---|---|---|---|
| White/Caucasian | 52 | 49 | 101 |
| Black | 3 | 3 | 6 |
| Asian | 0 | 1 | 1 |
| American Indian | 0 | 0 | 0 |
| Native Hawaiian or Pacific Islander | 1 | 0 | 1 |
| Other | 1 | 2 | 3 |
| Region of Enrollment(participants) | LB1148 | Placebo | Total |
|---|---|---|---|
| United States | 57 | 55 | 112 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Tranexamic Acid · Protease Inhibitor Formulation LB1148
Palisade Bio