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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Double-Blind Placebo-Controlled Dose Finding Study to Evaluate Safety/Efficacy of Ipamorelin Compared to Placebo for Recovery of Gastrointestinal Function in Patients Following Small or Large Bowel Resection w/Primary Anastomosis

Conditions
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Gastrointestinal Dysmotility

Intervention / Treatment
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* Drug: Saline Solution for Injection
* Drug: Ipamorelin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.03 mg/kg BID<br>Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion) | Drug: Ipamorelin<br>* Intravenous (IV)<br>|
| Experimental: 0.06 mg/kg BID<br>Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion) | Drug: Ipamorelin<br>* Intravenous (IV)<br>|
| Experimental: 0.06 mg/kg TID<br>Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions) | Drug: Ipamorelin<br>* Intravenous (IV)<br>|
| Placebo Comparator: Placebo<br>Matching placebo, TID (3 placebo infusions) | Drug: Saline Solution for Injection<br>* Intravenous (IV)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of Gastrointestinal (GI) Function | To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ancillary GI Functions | To investigate the effect of ipamorelin on ancillary efficacy measures of GI function and recovery | Up to 10 days or until hospital discharge | 
| Number of Subjects with Adverse Events as a Measure of Safety and Tolerability | 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 | 14 day outpatient follow-up visit |