Ileus Clinical Trial
— PROFILEOfficial 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
Verified date | April 2024 |
Source | Palisade Bio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 112 |
Est. completion date | September 8, 2023 |
Est. primary completion date | September 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 informed consent. 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. American Society of Anesthesiologists (ASA) Class 4 or 5. 5. Known inability to take the study drug orally (i.e. complete small bowel obstruction). 6. Has contraindications 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 contraceptive 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 (EnteregĀ®) during study participation period. 12. Planned use of 4% icodextrin (AdeptĀ®) or SEPRAFILM during the first surgery. 13. Received any other investigational therapy within 4 weeks prior to Randomization 14. 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. 15. Known history of radiation enteritis. |
Country | Name | City | State |
---|---|---|---|
United States | Site 321 | Baltimore | Maryland |
United States | Site 324 | Burlington | Massachusetts |
United States | Site 318 | Chapel Hill | North Carolina |
United States | Site 327 | Charleston | South Carolina |
United States | Site 306 | Clearwater | Florida |
United States | Site 301 | Cleveland | Ohio |
United States | Site 320 | Dallas | Texas |
United States | Site 316 | Fort Worth | Texas |
United States | Sie 309 | Houston | Texas |
United States | Site 311 | Houston | Texas |
United States | Site 319 | Houston | Texas |
United States | Site 329 | Irvine | California |
United States | Site 328 | Louisville | Kentucky |
United States | Site 303 | Miami | Florida |
United States | Site 305 | Miami | Florida |
United States | Site 331 | Miami | Florida |
United States | Site 315 | Mobile | Alabama |
United States | Site 317 | New York | New York |
United States | Site 323 | New York | New York |
United States | Site 308 | Orlando | Florida |
United States | Site 310 | Pasadena | California |
United States | Site 322 | Pittsburgh | Pennsylvania |
United States | Site 325 | Rochester | Minnesota |
United States | Site 326 | Salt Lake City | Utah |
United States | Site 302 | Sylmar | California |
United States | Site 312 | Torrance | California |
United States | Site 330 | Wynnewood | Pennsylvania |
United States | Site 307 | Yuma | Arizona |
Lead Sponsor | Collaborator |
---|---|
Palisade Bio |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | up to 8 months from the index surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00065234 -
Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus)
|
Phase 2 | |
Completed |
NCT01156129 -
Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery
|
Phase 1 | |
Recruiting |
NCT05712525 -
Gut Recovery In Patients Following Surgery
|
||
Completed |
NCT06338813 -
Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus
|
N/A | |
Recruiting |
NCT05315765 -
Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
|
||
Completed |
NCT02161367 -
Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery
|
Phase 4 | |
Completed |
NCT03711487 -
The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection
|
Phase 2 | |
Completed |
NCT00528970 -
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
|
Phase 3 | |
Not yet recruiting |
NCT04001985 -
Nasogastric Tube Clamping Trial vs. Immediate Removal
|
N/A | |
Completed |
NCT04100447 -
A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection
|
Phase 1 | |
Active, not recruiting |
NCT03795467 -
Peripheral Perfusion Index, Haemoglobin and Blood Transfusion in Acute Surgical Patients
|
||
Completed |
NCT01143259 -
Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use
|
N/A | |
Terminated |
NCT03352414 -
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
|
Phase 2 | |
Not yet recruiting |
NCT04305730 -
Use of Pedometer Following Radical Cystectomy
|
N/A | |
Completed |
NCT02760290 -
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique
|
N/A | |
Active, not recruiting |
NCT02399605 -
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus
|
N/A | |
Completed |
NCT00388258 -
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
|
Phase 3 | |
Terminated |
NCT05470387 -
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
|
Phase 3 | |
Completed |
NCT00205842 -
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
|
Phase 3 | |
Enrolling by invitation |
NCT05298774 -
Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function
|
N/A |