Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Saline Solution for Injection	Matching placebo, TID (3 placebo infusions)
0.03 mg/kg BID	Ipamorelin	Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)
0.06 mg/kg BID	Ipamorelin	Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)
0.06 mg/kg TID	Ipamorelin	Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions)

Primary Outcome Measures

Name	Time	Method
Recovery of Gastrointestinal (GI) Function	Up to 10 days	To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo

Secondary Outcome Measures

Name	Time	Method
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