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

This study is currently recruiting participants.
Verified April 2013 by Helsinn Therapeutics (U.S.), Inc
Sponsor:
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT01280344
First received: January 13, 2011
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Gastrointestinal Dysmotility
 Drug: Ipamorelin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Helsinn Therapeutics (U.S.), Inc:

Primary Outcome Measures:
  • Recovery of Gastrointestinal (GI) Function [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
    To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo


Secondary Outcome Measures:
  • Ancillary GI Functions [ Time Frame: Up to 10 days or until hospital discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 320
Study Start Date: March 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: x mg/kg twice daily (BID) Drug: Ipamorelin
Intravenously (IV)
Experimental: y mg/kg BID Drug: Ipamorelin
Intravenously (IV)
Experimental: y mg/kg three times daily (TID) Drug: Ipamorelin
Intravenously (IV)
Placebo Comparator: Placebo Drug: Ipamorelin
Intravenously (IV)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280344

Contacts
Contact: Suzan Allen ipam@helsinnthera.com

  Show 45 Study Locations
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
  More Information

No publications provided

Responsible Party: Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier: NCT01280344     History of Changes
Other Study ID Numbers: HT-IPAM-202
Study First Received: January 13, 2011
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013