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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastrointestinal Dysmotility

In brief

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.

Key facts

Study ID

NCT01280344

Run by

Helsinn Therapeutics (U.S.), Inc

People needed

320

Starts

2011-04-01

Expected to finish

2014-05-01

Last updated by the study team

2017-04-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Florence, Alabama, United States
• Study site — Sheffield, Alabama, United States
• Study site — Fountain Valley, California, United States
• Study site — Glendale, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Aventura, Florida, United States
• Study site — Inverness, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Weston, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Highland Park, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Iowa City, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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