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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01280344
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Dysmotility Drug: Saline Solution for Injection Drug: Ipamorelin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : May 2014
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Recovery of Gastrointestinal (GI) Function [ Time Frame: Up to 10 days ]
    To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo


Secondary Outcome Measures :
  1. 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

  2. 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 Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280344


Locations
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United States, Alabama
Florence, Alabama, United States
Sheffield, Alabama, United States
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
United States, Colorado
Aurora, Colorado, United States
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
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Highland Park, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Des Moines, Iowa, United States
Iowa City, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Flint, Michigan, United States
Royal Oak, Michigan, United States
Troy, Michigan, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
Stony Brook, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
Nassau Bay, Texas, United States
United States, Vermont
Burlington, Vermont, United States
United States, Washington
Bellevue, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
More Information
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Responsible Party: Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier: NCT01280344    
Other Study ID Numbers: HT-IPAM-202
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017