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

Helsinn Healthcare

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Dysmotility

Treatments: Drug: Ipamorelin; Drug: Saline Solution for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01280344

HT-IPAM-202

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

320 participants in 4 patient groups, including a placebo group

0.03 mg/kg BID

Experimental group

Description:

Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)

Treatment:

Drug: Ipamorelin

0.06 mg/kg BID

Experimental group

Description:

Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)

Treatment:

Drug: Ipamorelin

0.06 mg/kg TID

Experimental group

Description:

Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions)

Treatment:

Drug: Ipamorelin

Placebo

Placebo Comparator group

Description:

Matching placebo, TID (3 placebo infusions)

Treatment:

Drug: Saline Solution for Injection