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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT00672074 (opens ClinicalTrials.gov in a new tab)Other idST-IPAM-201
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
117 participants (actual)
Sponsor
Helsinn Therapeutics (U.S.), Inc · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Apr 2008
Primary completion
Dec 2009
Completion
Dec 2009
First posted
6 May 2008 (estimated)
Last update posted
14 Apr 2017
Conditions
Ileus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010
  1. Ph 2

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

    NCT00672074

    Apr 2008 to Dec 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.

Interventions

  • IpamorelinDrug
  • placeboDrug

Arms2

  • Active comparator

    1 Ipamorelin

  • Placebo comparator

    2 Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Recovery of GI function

    Time frame · Until hospital discharge

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

3 results

Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients.

Beck et al. 2014International journal of colorectal diseasecited by 19

PMID 25331030DOI 10.1007/s00384-014-2030-8PUB-25331030

Full text at the publisher3 results
Publisher pageSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * willing to comply with protocol * undergoing bowel resection surgery * ASA Class I-III * Females must not be pregnant * Body weight 40-150 kg Exclusion Criteria: * mentally incompetent or unable to provide informed consent * clinically unstable * significant liver disease * clinically significant lab or EKG abnormalities * alcohol or illicit drug abuse * history of or current surgery that would prevent proper evaluation of safety or efficacy of drug

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