Current partner codePEPTIDESDE
NCT01280344·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

320

Locations

45

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Saline Solution for Injection

Intravenous (IV)

DRUG

Ipamorelin

Intravenous (IV)

Timeline

From registration to results.

  1. First posted

    Jan 20, 2011

  2. Study start

    Apr 2011

  3. Primary completion

    Jun 2013

  4. Study completion

    May 2014

  5. Results posted

    Not reported

  6. Registry updated

    Apr 13, 2017

Outcomes

What the study measures.

Primary outcomes

Recovery of Gastrointestinal (GI) Function

Time frame · Up to 10 days

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

Secondary outcomes

Ancillary GI Functions

Time frame · Up to 10 days or until hospital discharge

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

Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

Time frame · 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

Who can take part.

Minimum age
18 Years
Maximum age
85 Years
Sex
ALL
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

Study locations

45 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Facility not named

Florence, Alabama, United States

Facility not named

Sheffield, Alabama, United States

Facility not named

Fountain Valley, California, United States

Facility not named

Glendale, California, United States

Facility not named

Laguna Hills, California, United States

Facility not named

Los Angeles, California, United States

Facility not named

Orange, California, United States

Facility not named

San Francisco, California, United States

Facility not named

Aurora, Colorado, United States

Facility not named

Aventura, Florida, United States

Facility not named

Inverness, Florida, United States

Facility not named

Miami, Florida, United States

Facility not named

Orlando, Florida, United States

Facility not named

Pensacola, Florida, United States

Facility not named

Sarasota, Florida, United States

Facility not named

Tampa, Florida, United States

Facility not named

Weston, Florida, United States

Facility not named

Atlanta, Georgia, United States

Facility not named

Chicago, Illinois, United States

Facility not named

Highland Park, Illinois, United States

Facility not named

Indianapolis, Indiana, United States

Facility not named

Des Moines, Iowa, United States

Facility not named

Iowa City, Iowa, United States

Facility not named

Kansas City, Kansas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.