Clinical trial NCT01280344: Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Dysmotility
Lead sponsor: Helsinn Therapeutics (U.S.), Inc
Sponsor class: INDUSTRY
First posted: 2011-01-20
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Recovery of Gastrointestinal (GI) Function
timeFrame: Up to 10 days
Secondary outcomes:
measure: Ancillary GI Functions
timeFrame: Up to 10 days or until hospital discharge
measure: Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 14 day outpatient follow-up visit
Other outcomes:
Locations:
city: Florence
country: United States
state: Alabama
city: Sheffield
country: United States
state: Alabama
city: Fountain Valley
country: United States
state: California
city: Glendale
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Aventura
country: United States
state: Florida
city: Inverness
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Highland Park
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Springfield
country: United States
state: Massachusetts
city: Flint
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Stony Brook
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Nassau Bay
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Bellevue
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
References: