Gastrointestinal Dysmotility
Conditions
Brief summary
Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.
Interventions
Intravenous (IV)
DRUGIpamorelin
Intravenous (IV)
Sponsors
Helsinn Therapeutics (U.S.), Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form * Males or females, 18 to 85 years of age inclusive at the time of study screening * American Society of Anesthesiologists (ASA) Class I-III * Have undergone a scheduled small and/or large open partial bowel resection based on a documented incision size greater than or equal to (≥) 10 cm with primary anastomosis * Females must not be pregnant as confirmed by a serum pregnancy test at screening and by a urine pregnancy test on the day of surgery * Body weight must be between 40-150 kilograms (kg)
Exclusion criteria
* Any procedure which requires a diverting stoma * Primary anastomosis not performed at the time of surgery * Epidural or intrathecal anesthesia * Significant liver disease (ALT and/or total bilirubin \> 2-fold upper limits of normal) or kidney disease (serum creatinine \> 2.5 mg/dL) at screening * History of irritable bowel syndrome * Patients with a history of Crohn's disease or ulcerative colitis (UC) who have had multiple GI-related surgeries (Note: surgery naïve Crohn's or UC patients may be included) * History of colonic volvulus * History of gastroesophageal surgery, gastrectomy, gastric bypass, total colectomy, short bowel syndrome, or multiple complex abdominal surgeries performed by an open procedure (uncomplicated cesarean section and appendectomy would not be considered complex) * Patients who have received prior abdominal radiation and/or pelvic radiation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of Gastrointestinal (GI) Function | Up to 10 days | To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ancillary GI Functions | Up to 10 days or until hospital discharge | To investigate the effect of ipamorelin on ancillary efficacy measures of GI function and recovery |
| Number of Subjects with Adverse Events as a Measure of Safety and Tolerability | 14 day outpatient follow-up visit | To investigate the safety and tolerability of ipamorelin laboratory and clinical parameters, incidence of adverse events, until hospital discharge, 14-day outpatient follow-up visit, or until resolution of adverse events |
Countries
United States
Outcome results
None listed