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Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

NCT02558829 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2018-04-10

Study results available
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Summary

The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial. The trial will include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of healthy control subjects.

Conditions

  • Growth Hormone Deficiency With Pituitary Anomalies

Interventions

DRUG

Macimorelin

macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose

DRUG

Insulin

Insulin, 0.10 U/kg (0.15 U/kg if BMI \> 30 kg/m2), intravenous injection, single dose

Sponsors & Collaborators

  • AEterna Zentaris

    lead INDUSTRY

Principal Investigators

  • Jose M Garcia, MD PhD · Baylor College of Medicine, Houston, TX, U.S.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-03
Primary Completion
2016-11-29
Completion
2016-11-29

Countries

  • United States
  • Austria
  • France
  • Germany
  • Italy
  • Poland
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02558829 on ClinicalTrials.gov