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

• Sponsor: Helsinn Therapeutics (U.S.), Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01280344
• Collaborator: (none)
• Enrollment: 320
• Locations: 45
• Arms: 4
• Actual Duration (Months): 37
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Dysmotility	Drug: Saline Solution for Injection; Drug: Ipamorelin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.03 mg/kg BID Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)	Drug: Ipamorelin; Intravenous (IV)
Experimental: 0.06 mg/kg BID Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)	Drug: Ipamorelin; Intravenous (IV)
Experimental: 0.06 mg/kg TID Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions)	Drug: Ipamorelin; Intravenous (IV)
Placebo Comparator: Placebo Matching placebo, TID (3 placebo infusions)	Drug: Saline Solution for Injection; Intravenous (IV)

Outcome Measures

Primary Outcome Measures

1. Recovery of Gastrointestinal (GI) Function [Up to 10 days]

   To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo

Secondary Outcome Measures

1. Ancillary GI Functions [Up to 10 days or until hospital discharge]

   To investigate the effect of ipamorelin on ancillary efficacy measures of GI function and recovery

2. Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [14 day outpatient follow-up visit]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Florence	Alabama	United States
2		Sheffield	Alabama	United States
3		Fountain Valley	California	United States
4		Glendale	California	United States
5		Laguna Hills	California	United States
6		Los Angeles	California	United States
7		Orange	California	United States
8		San Francisco	California	United States
9		Aurora	Colorado	United States
10		Aventura	Florida	United States
11		Inverness	Florida	United States
12		Miami	Florida	United States
13		Orlando	Florida	United States
14		Pensacola	Florida	United States
15		Sarasota	Florida	United States
16		Tampa	Florida	United States
17		Weston	Florida	United States
18		Atlanta	Georgia	United States
19		Chicago	Illinois	United States
20		Highland Park	Illinois	United States
21		Indianapolis	Indiana	United States
22		Des Moines	Iowa	United States
23		Iowa City	Iowa	United States
24		Kansas City	Kansas	United States
25		New Orleans	Louisiana	United States
26		Springfield	Massachusetts	United States
27		Flint	Michigan	United States
28		Royal Oak	Michigan	United States
29		Troy	Michigan	United States
30		Jackson	Mississippi	United States
31		St. Louis	Missouri	United States
32		Stony Brook	New York	United States
33		Chapel Hill	North Carolina	United States
34		Cincinnati	Ohio	United States
35		Cleveland	Ohio	United States
36		Columbus	Ohio	United States
37		Hershey	Pennsylvania	United States
38		Pittsburgh	Pennsylvania	United States
39		Memphis	Tennessee	United States
40		Nashville	Tennessee	United States
41		Houston	Texas	United States
42		Nassau Bay	Texas	United States
43		Burlington	Vermont	United States
44		Bellevue	Washington	United States
45		Milwaukee	Wisconsin	United States

Sponsors and Collaborators

• Helsinn Therapeutics (U.S.), Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helsinn Therapeutics (U.S.), Inc
• ClinicalTrials.gov Identifier: NCT01280344
• Other Study ID Numbers: HT-IPAM-202
• First Posted: Jan 20, 2011
• Last Update Posted: Apr 13, 2017
• Last Verified: Apr 1, 2017

Study Results

No Results Posted as of Apr 13, 2017