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

Gastrointestinal Dysmotility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280344
• Other study ID #: HT-IPAM-202
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2011
• Last updated: April 12, 2017
• Start date: April 2011
• Est. completion date: May 2014

Study information

• Verified date: April 2017
• Source: Helsinn Therapeutics (U.S.), Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: May 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Dysmotility

Intervention

Drug:
• Saline Solution for Injection
Intravenous (IV)
• Ipamorelin
Intravenous (IV)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinn Therapeutics (U.S.), Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of Gastrointestinal (GI) Function	To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo	Up to 10 days
Secondary	Ancillary GI Functions	To investigate the effect of ipamorelin on ancillary efficacy measures of GI function and recovery	Up to 10 days or until hospital discharge
Secondary	Number of Subjects with Adverse Events as a Measure of Safety and Tolerability	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	14 day outpatient follow-up visit