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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Dysmotility
• Intervention / Treatment: Drug: Ipamorelin; Drug: Saline Solution for Injection

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Florence, Alabama, United States
    • Sheffield, Alabama, United States
  • California
    • Fountain Valley, California, United States
    • Glendale, California, United States
    • Laguna Hills, California, United States
    • Los Angeles, California, United States
    • Orange, California, United States
    • San Francisco, California, United States
  • Colorado
    • Aurora, Colorado, United States
  • Florida
    • Aventura, Florida, United States
    • Inverness, Florida, United States
    • Miami, Florida, United States
    • Orlando, Florida, United States
    • Pensacola, Florida, United States
    • Sarasota, Florida, United States
    • Tampa, Florida, United States
    • Weston, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
    • Highland Park, Illinois, United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Iowa
    • Des Moines, Iowa, United States
    • Iowa City, Iowa, United States
  • Kansas
    • Kansas City, Kansas, United States
  • Louisiana
    • New Orleans, Louisiana, United States
  • Massachusetts
    • Springfield, Massachusetts, United States
  • Michigan
    • Flint, Michigan, United States
    • Royal Oak, Michigan, United States
    • Troy, Michigan, United States
  • Mississippi
    • Jackson, Mississippi, United States
  • Missouri
    • St. Louis, Missouri, United States
  • New York
    • Stony Brook, New York, United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
    • Columbus, Ohio, United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States
    • Pittsburgh, Pennsylvania, United States
  • Tennessee
    • Memphis, Tennessee, United States
    • Nashville, Tennessee, United States
  • Texas
    • Houston, Texas, United States
    • Nassau Bay, Texas, United States
  • Vermont
    • Burlington, Vermont, United States
  • Washington
    • Bellevue, Washington, United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helsinn Therapeutics (U.S.), Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 13, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (Estimate): January 20, 2011

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HT-IPAM-202