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The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing elective bowel resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LB1148 | Experimental | active |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LB1148 | Drug | A total of 700 mL of LB1148 will be administered orally as a split dose before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach GI-2 | • GI-2 is defined as the toleration of solid food and first bowel movement.
| within 14 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach GI-3 | • GI-3 is defined as the toleration of solid food and either first flatus or bowel movement. | within 14 days after surgery |
| Nausea Verbal Rating Scoring Scale | • To assess the nausea and ability to tolerate food |
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Inclusion Criteria:
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.
Insulin dependent diabetes mellitus.
Known inability to take the study drug orally (i.e. complete small bowel obstruction).
Has contraindications or potential risk factors to taking tranexamic acid (TXA). These include subjects with:
Known allergic reaction to polyethylene glycol (PEG) 4000 powder, combination formulation of polyethylene glycol (PEG) and electrolyte powder, polyethylene glycol (PEG) 3350 solution and glucose formulation.
Has the following risk factors for thromboembolic disease:
Known medical history of congenital or acquired thrombophilia such as, but not limited to patients with:
Stage IV malignant neoplasm;
Neurologic paresis, partial paralysis, or paralysis;
Pacemaker;
History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or rental venous/arterial occlusion;
History of or current seizure disorder.
Patients with myeloproliferative disorders.
Body Mass Index (BMI) >40.
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.
Received any other investigational therapy within 4 weeks prior to Randomization
Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | |||
| General Hospital of Xuzhou Mining Group |
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| ID | Term |
|---|---|
| D045823 | Ileus |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Drug | A total of 700 mL of placebo will be administered orally as a split dose before surgery. |
|
| within 14 days after surgery |
| Number of days in the hospital | • Length of Stay (number of days in the hospital, evaluated in hours) will be measured by time to
| within 14 days after surgery |
| Xuzhou |
| Jiangsu |
| China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | China |
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
| Ningbo First Hospital | Ningbo | Zhejiang | China |