DRUG
Saline Solution for Injection
Intravenous (IV)
Status
Completed
Phase
Phase 2
Enrollment
320
Locations
45
Results
Not posted
Publications
0
Study 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
DRUG
Intravenous (IV)
DRUG
Intravenous (IV)
Timeline
First posted
Jan 20, 2011
Study start
Apr 2011
Primary completion
Jun 2013
Study completion
May 2014
Results posted
Not reported
Registry updated
Apr 13, 2017
Outcomes
Recovery of Gastrointestinal (GI) Function
Time frame · Up to 10 days
To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo
Ancillary GI Functions
Time frame · 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
Time frame · 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
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Florence, Alabama, United States
Facility not named
Sheffield, Alabama, United States
Facility not named
Fountain Valley, California, United States
Facility not named
Glendale, California, United States
Facility not named
Laguna Hills, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Orange, California, United States
Facility not named
San Francisco, California, United States
Facility not named
Aurora, Colorado, United States
Facility not named
Aventura, Florida, United States
Facility not named
Inverness, Florida, United States
Facility not named
Miami, Florida, United States
Facility not named
Orlando, Florida, United States
Facility not named
Pensacola, Florida, United States
Facility not named
Sarasota, Florida, United States
Facility not named
Tampa, Florida, United States
Facility not named
Weston, Florida, United States
Facility not named
Atlanta, Georgia, United States
Facility not named
Chicago, Illinois, United States
Facility not named
Highland Park, Illinois, United States
Facility not named
Indianapolis, Indiana, United States
Facility not named
Des Moines, Iowa, United States
Facility not named
Iowa City, Iowa, United States
Facility not named
Kansas City, Kansas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.