IleusPhase 2PROFILENCT02836470
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
A Phase 2 study testing LB1148 in people with Ileus and Post-Operative Adhesions, run by Palisade Bio at 28 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ileus, Post-Operative Adhesions
- What is being tested?
- LB1148
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 28 sitesUnited States
- Study dates
- 1 Oct 2019to 8 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:
- 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.
- Planned stoma takedown or other planned abdominal surgery within 8 months of the initial surgery.
- 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.
- 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.
Who cannot join
- Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:
- <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.
Show all 23Show fewer
- Known inability to take the study drug orally (i.e. complete small bowel obstruction).
- Has contraindications or potential risk factors to taking TXA. These include subjects with:
- Known sensitivity to 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).
- Has peritoneal carcinomatosis
- History of or current seizure disorder.
- Patients with myeloproliferative disorders.
- 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.
- Planned treatment with alvimopan (Entereg®) during study participation period.
- Planned use of 4% icodextrin (Adept®) or SEPRAFILM during the first surgery.
- Received any other investigational therapy within 4 weeks prior to Randomization
- 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.
- Known history of radiation enteritis.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Site 321
Baltimore, Maryland, 21237
Site 324
Burlington, Massachusetts, 01850
Site 318
Chapel Hill, North Carolina, 27599
Site 327
Charleston, South Carolina, 29425
Site 306
Clearwater, Florida, 33756
Site 301
Cleveland, Ohio, 44195
Site 320
Dallas, Texas, 75390
Site 316
Fort Worth, Texas, 76104
Site 311
Houston, Texas, 77024
Site 319
Houston, Texas, 77030
Sie 309
Houston, Texas, 77089
Site 329
Irvine, California, 92868
Site 328
Louisville, Kentucky, 40202
Site 303
Miami, Florida, 33125
Site 331
Miami, Florida, 33126
Site 305
Miami, Florida, 33142
Site 315
Mobile, Alabama, 36617
Site 317
New York, New York, 10029
Site 323
New York, New York, 10075
Site 308
Orlando, Florida, 32804
Site 310
Pasadena, California, 91105
Site 322
Pittsburgh, Pennsylvania, 15212
Site 325
Rochester, Minnesota, 55905
Site 326
Salt Lake City, Utah, 84132
Site 302
Sylmar, California, 91342
Site 312
Torrance, California, 90502
Site 330
Wynnewood, Pennsylvania, 19096
Site 307
Yuma, Arizona, 85364
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Post-Operative Ileus and Intra-Abdominal Adhesions in Subjects Undergoing Elective Bowel Resection
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.
- Conditions
- Ileus, Post-Operative Adhesions
- Being tested
- LB1148, Placebo
- Keywords
- Post-operative Ileus, Post-Operative Abdominal Adhesions, Return of Gastrointestinal Function, Anastomosis, Enterotomy, Enterostomy, Colorectal Surgery, Intestines Surgery
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB1148Drug
Also called Active
A total of 700 mL of drug product will be administered orally as a split dose before surgery.
PlaceboDrug
A total of 700 mL of placebo will be administered orally as a split dose before surgery.
| Study group | Role | What they receive |
|---|---|---|
| LB1148 | Experimental | Active Receives: Drug: LB1148 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 8 months from the index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start1 Oct 2019
- Primary completion6 Sep 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palisade Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitch Jones, MD, Study director, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836470
- Sponsor's protocol ID
- LBS-POI-201
- Acronym
- PROFILE
- Status last verified
- Apr 2024
- First submitted
- 13 Jul 2016
- Last updated
- 21 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Post-Operative Ileus and Intra-Abdominal Adhesions in Subjects Undergoing Elective Bowel Resection
- ClinicalTrials.gov ID
- NCT02836470
- Acronym / sponsor ID
- PROFILE / LBS-POI-201
- Conditions
- Ileus, Post-Operative Adhesions
- Keywords
- Post-operative Ileus, Post-Operative Abdominal Adhesions, Return of Gastrointestinal Function, Anastomosis, Enterotomy, Enterostomy, Colorectal Surgery, Intestines Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Palisade BioIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Posted 21 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LB1148 | Experimental | Drug: LB1148Active |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:
- 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.
- Planned stoma takedown or other planned abdominal surgery within 8 months of the initial surgery.
- 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.
- 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.
Key exclusion criteria (23 listed)
- Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:
- <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB1148Also: ActiveA total of 700 mL of drug product will be administered orally as a split dose before surgery. | Drug | LB1148 |
| PlaceboA total of 700 mL of placebo will be administered orally as a split dose before surgery. | Drug | Placebo |
Primary outcome
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo
Time frame: up to 8 months from the index surgery
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ileus
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingObservational study
The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
Ostomy - Ileostomy or Colostomy, Canser
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Not yet recruitingPhase 2
TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
Delay in GI Recovery/Postoperative Ileus (POI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitch Jones, MD study director
CMO
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LB1148 in people with Ileus and Post-Operative Adhesions, run by Palisade Bio at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo (time frame: up to 8 months from the index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.