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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT01280344
First received: January 13, 2011
Last updated: August 30, 2013
Last verified: August 2013

January 13, 2011
August 30, 2013
March 2011
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01280344 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastrointestinal Dysmotility
Drug: Ipamorelin
Intravenously (IV)
  • Experimental: x mg/kg twice daily (BID)
    Intervention: Drug: Ipamorelin
  • Experimental: y mg/kg BID
    Intervention: Drug: Ipamorelin
  • Experimental: y mg/kg three times daily (TID)
    Intervention: Drug: Ipamorelin
  • Placebo Comparator: Placebo
    Intervention: Drug: Ipamorelin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
Not Provided
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01280344
HT-IPAM-202
No
Helsinn Therapeutics (U.S.), Inc
Helsinn Therapeutics (U.S.), Inc
Not Provided
Not Provided
Helsinn Therapeutics (U.S.), Inc
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP