Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus

Plain-language guide to NCT00672074: phase 2 randomized trial of CJC-1295 (no DAC) (with/without DAC) + Ipamorelin and Ipamorelin, 117 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00672074
Phase: phase 2
Status: completed
Start: 2008-04
Completion (planned or actual): 2009-12
Participants: 117 (actual)
Design: randomized, quadruple-blind, treatment
Conditions studied: Ileus
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested CJC-1295 (no DAC) (with/without DAC) + Ipamorelin and Ipamorelin.

It had two arms (groups): 1 Ipamorelin (active comparator) and 2 Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 117 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: Willing to comply with protocol. Undergoing bowel resection surgery. ASA Class I-III. Females must not be pregnant. Body weight 40-150 kg.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: mentally incompetent or unable to provide informed consent; clinically unstable; alcohol or illicit drug abuse.

How the Study Was Run

The set-up was 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.

As a double-blind CJC-1295 (no DAC) (with/without DAC) + Ipamorelin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2008-04 with completion listed for 2009-12.

It ran at 19 sites in United States (19).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Recovery of GI function (time frame: Until hospital discharge).

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 117 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.

Our Notes on the Compounds

CJC-1295 (no DAC) (with/without DAC) + Ipamorelin: GH secretagogues, preferred over exogenous HGH because the body keeps its pulsatile release and feedback control.

Ipamorelin: A selective ghrelin-receptor agonist (growth hormone secretagogue) studied in human pharmacology and a postoperative ileus trial.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.