Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function
NCT ID: NCT01280344
Last Updated: 2017-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
320 participants
INTERVENTIONAL
2011-04-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.03 mg/kg BID
Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)
Ipamorelin
Intravenous (IV)
0.06 mg/kg BID
Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)
Ipamorelin
Intravenous (IV)
0.06 mg/kg TID
Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions)
Ipamorelin
Intravenous (IV)
Placebo
Matching placebo, TID (3 placebo infusions)
Saline Solution for Injection
Intravenous (IV)
Interventions
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Saline Solution for Injection
Intravenous (IV)
Ipamorelin
Intravenous (IV)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Helsinn Therapeutics (U.S.), Inc
INDUSTRY
Responsible Party
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Locations
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Florence, Alabama, United States
Sheffield, Alabama, United States
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
Aurora, Colorado, United States
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
Atlanta, Georgia, United States
Chicago, Illinois, United States
Highland Park, Illinois, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Springfield, Massachusetts, United States
Flint, Michigan, United States
Royal Oak, Michigan, United States
Troy, Michigan, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Stony Brook, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Nassau Bay, Texas, United States
Burlington, Vermont, United States
Bellevue, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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HT-IPAM-202
Identifier Type: -
Identifier Source: org_study_id
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