IleusPhase 3INTEGRITYNCT05470387
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
A Phase 3 study testing LB1148 in people with Ileus and Gastro-Intestinal Disorder, run by Palisade Bio at 23 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ileus, Gastro-Intestinal Disorder
- 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
- 23 participants
- Where
- 23 sitesUnited States
- Study dates
- 28 Jun 2022to 11 Aug 2023
- Phase
- Phase 3
- 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:
- Adults age 18 to 80 years, inclusive.
- Scheduled to undergo a planned (non-emergent) bowel resection via minimally invasive technique or laparotomy. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elective indication.
- Willing to perform and comply with all study procedures including, being hospitalized until achieving GI-2 and responding to telephone follow-up visits as scheduled.
- Willing and able to provide 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:
- History of total colectomy.
- Has a preexisting ostomy.
- History of radiation enteritis.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
- History of seizure disorder.
Show all 21Show fewer
- History of myeloproliferative disorders.
- American Society of Anesthesiologists (ASA) Class IV or V.
- Inability to take IP orally or consume solid food.
- Planned treatment with alvimopan (Entereg®) during hospitalization period
- Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
- Men and women of child bearing potential (WOCBP) who are unwilling to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods (but not combination hormonal methods), intrauterine device, or use of spermicide combined with a barrier method (e.g., condom, diaphragm) for 28 days before Day 1 and through Day 30.
- Women who will not agree to stop combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch or vaginal ring) during the 7 day period prior to Surgery (Study Day 2) through the 7 day period following surgery (Study Days 3 through 9).
- 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
- Receipt of any investigational drug within 28 days or 5 half-lives prior to Day 1.
- Any other condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Site 321
Baltimore, Maryland, 21237
Site 359
Bridgeport, Connecticut, 06610
Site 324
Burlington, Massachusetts, 01805
Site 318
Chapel Hill, North Carolina, 27599
Site 351
Clearwater, Florida, 33756
Site 313
Columbus, Ohio, 43210
Site 320
Dallas, Texas, 75390
Site 355
Grand Rapids, Michigan, 49503
Site 319
Houston, Texas, 77030
Site 357
Iowa City, Iowa, 52242
Site 358
Jacksonville, Florida, 32224
Site 354
La Jolla, California, 92037
Site 331
Miami, Florida, 33136
Site 315
Mobile, Alabama, 36617
Site 317
New York, New York, 10029
Site 356
New York, New York, 10032
Site 329
Orange, California, 92868
Site 353
Providence, Rhode Island, 02906
Site 325
Rochester, Minnesota, 55905
Site 326
Salt Lake City, Utah, 84132
Site 350
San Diego, California, 92123
Site 352
St Louis, Missouri, 63110
Site 312
Torrance, California, 90502
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of LB1148 in Accelerating the Time to Return of Bowel Function in Subjects Undergoing Planned Bowel Resection (INTEGRITY)
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
Read the detailed description
This will be a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the safety and efficacy of LB1148 in return to bowel function for subjects undergoing planned bowel resection.
- Conditions
- Ileus, Gastro-Intestinal Disorder
- Being tested
- LB1148, Placebo
- Keywords
- post operative ileus, return of bowel function, return of gastrointestinal function, enterotomy, colon surgery, colorectal surgery, intestinal surgery
- Medical subject headings
- Ileus, Digestive System Diseases
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 | Not described Receives: Drug: LB1148 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Return of Gastrointestinal Function
The later of the times in hours from placement of the last skin staple or suture to the time of toleration of solid food (defined as the time a subject finished a meal that required chewing and experienced no significant nausea/vomiting for 4 hours after the solid meal) and the first bowel movement, up to 14 days post-surgery
Measured: From surgical procedure up to 14 days in hospital
Secondary outcomes (4)
Time to First Bowel Movement
Time in hours from placement of the last skin staple or suture to the time of first bowel movement
Measured: From surgical procedure up to 14 days in hospital
Time Subject is Ready for Discharge
Time subject is ready for discharge, defined as the time from the end of surgery to the time the subject is ready for hospital discharge solely based on the recovery of GI function, as determined by the surgeon
Measured: From surgical procedure up to 14 days in hospital
Time Discharge Order Written
Time discharge order written, defined as the time from the end of surgery to the time that the hospital discharge order is written
Measured: From surgical procedure up to 14 days in hospital
Time of Actual Discharge
Time of actual discharge, defined as the time from the end of surgery to the time the subject is actually discharged from the hospital
Measured: From surgical procedure up to 14 days in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start28 Jun 2022
- Primary completion6 Mar 2023
- Study completion11 Aug 2023
Why it stopped: Company decision
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 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
- NCT05470387
- Sponsor's protocol ID
- PBI-POI-301
- Acronym
- INTEGRITY
- Status last verified
- Apr 2024
- First submitted
- 20 Jul 2022
- Last updated
- 13 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of LB1148 in Accelerating the Time to Return of Bowel Function in Subjects Undergoing Planned Bowel Resection (INTEGRITY)
- ClinicalTrials.gov ID
- NCT05470387
- Acronym / sponsor ID
- INTEGRITY / PBI-POI-301
- Conditions
- Ileus, Gastro-Intestinal Disorder
- Keywords
- post operative ileus, return of bowel function, return of gastrointestinal function, enterotomy, colon surgery, colorectal surgery, intestinal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Palisade BioIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Posted 13 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 evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
Detailed description
This will be a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the safety and efficacy of LB1148 in return to bowel function for subjects undergoing planned bowel resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LB1148 | Experimental | Drug: LB1148 |
| Placebo | Placebo comparator | Drug: Placebo |
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:
- Adults age 18 to 80 years, inclusive.
- Scheduled to undergo a planned (non-emergent) bowel resection via minimally invasive technique or laparotomy. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elective indication.
- Willing to perform and comply with all study procedures including, being hospitalized until achieving GI-2 and responding to telephone follow-up visits as scheduled.
- Willing and able to provide written informed consent.
Key exclusion criteria (21 listed)
- Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:
- History of total colectomy.
- Has a preexisting ostomy.
- History of radiation enteritis.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
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
Time to Return of Gastrointestinal Function
Time frame: From surgical procedure up to 14 days in hospital
The later of the times in hours from placement of the last skin staple or suture to the time of toleration of solid food (defined as the time a subject finished a meal that required chewing and experienced no significant nausea/vomiting for 4 hours after the solid meal) and the first bowel movement, up to 14 days post-surgery
4 secondary outcomes
Time to First Bowel Movement
Time frame: From surgical procedure up to 14 days in hospital
Time Subject is Ready for Discharge
Time frame: From surgical procedure up to 14 days in hospital
Time Discharge Order Written
Time frame: From surgical procedure up to 14 days in hospital
Time of Actual Discharge
Time frame: From surgical procedure up to 14 days in hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LB1148 in people with Ileus and Gastro-Intestinal Disorder, run by Palisade Bio at 23 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 21 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: stopped early, as of the sponsor's last update on 13 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 23 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 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?
Time to Return of Gastrointestinal Function (time frame: From surgical procedure up to 14 days in hospital). 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 13 Jun 2024.