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

What Was Tested

In this phase 2 trial, researchers set out to test CJC-1295 (no DAC) (with/without DAC) + Ipamorelin and Ipamorelin.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 320 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: any procedure which requires a diverting stoma; primary anastomosis not performed at the time of surgery; epidural or intrathecal anesthesia.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this CJC-1295 (no DAC) (with/without DAC) + Ipamorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The CJC-1295 (no DAC) (with/without DAC) + Ipamorelin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received CJC-1295 (no DAC) (with/without DAC) + Ipamorelin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-04 with completion listed for 2013-06.

It ran at 45 sites in United States (45).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Recovery of Gastrointestinal (GI) Function (time frame: Up to 10 days).

It also tracked 2 secondary outcomes, for example Ancillary GI Functions and Number of Subjects with Adverse Events as a Measure of Safety and Tolerability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of CJC-1295 (no DAC) (with/without DAC) + Ipamorelin and Ipamorelin in 320 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the CJC-1295 (no DAC) (with/without DAC) + Ipamorelin compound page and the Ipamorelin compound page, all human trials.