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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT01280344 (opens ClinicalTrials.gov in a new tab)Other idHT-IPAM-202
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
Apr 2011
Primary completion
Jun 2013
Completion
May 2014
First posted
20 Jan 2011 (estimated)
Last update posted
13 Apr 2017
Conditions
Gastrointestinal Dysmotility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph 2

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

    NCT01280344

    Apr 2011 to May 2014

Registry summary

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

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

  • Saline Solution for InjectionDrug
  • IpamorelinDrug

Arms4

  • Experimental

    0.03 mg/kg BID

    Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)

  • Experimental

    0.06 mg/kg BID

    Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)

  • Experimental

    0.06 mg/kg TID

    Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions)

  • Placebo comparator

    Placebo

    Matching placebo, TID (3 placebo infusions)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Recovery of Gastrointestinal (GI) Function

    Time frame · Up to 10 days

    Registry description

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

Secondary outcomes(2)

  1. Ancillary GI Functions

    Time frame · Up to 10 days or until hospital discharge

    Registry description

    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

    Time frame · 14 day outpatient follow-up visit

    Registry description

    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

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

Studies0

Studies that cite this trial.

No study cites this trial.

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: * 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

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