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
1 other identifier
interventional
320
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
Typical duration for phase_2
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2011
CompletedFirst Posted
Study publicly available on registry
January 20, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 13, 2017
April 1, 2017
2.2 years
January 13, 2011
April 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Recovery of Gastrointestinal (GI) Function
To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo
Up to 10 days
Secondary Outcomes (2)
Ancillary GI Functions
Up to 10 days or until hospital discharge
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
14 day outpatient follow-up visit
Study Arms (4)
0.03 mg/kg BID
EXPERIMENTALIpamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)
0.06 mg/kg BID
EXPERIMENTALIpamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)
0.06 mg/kg TID
EXPERIMENTALIpamorelin 0.06 mg/kg, TID (3 investigational drug infusions)
Placebo
PLACEBO COMPARATORMatching placebo, TID (3 placebo infusions)
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Unknown Facility
Florence, Alabama, United States
Unknown Facility
Sheffield, Alabama, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
Laguna Hills, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Orange, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
Inverness, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Pensacola, Florida, United States
Unknown Facility
Sarasota, Florida, United States
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Tampa, Florida, United States
Unknown Facility
Weston, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Highland Park, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Flint, Michigan, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Troy, Michigan, United States
Unknown Facility
Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Stony Brook, New York, United States
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Chapel Hill, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Hershey, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Nassau Bay, Texas, United States
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Burlington, Vermont, United States
Unknown Facility
Bellevue, Washington, United States
Unknown Facility
Milwaukee, Wisconsin, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2011
First Posted
January 20, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2013
Study Completion
May 1, 2014
Last Updated
April 13, 2017
Record last verified: 2017-04