Clinical Trial: Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (IT
Brief Summary: The Macimorelin-GHST (growth hormone stimulation test) will be compared with the ITT (insulin tolerance test) 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.
Detailed Summary:
Trial subjects will be assigned to groups of descending likelihood of having AGHD:
Group A, B, C: High, intermediate, and low likelihood of GHD, respectively; Group D: Healthy control subjects matching Group A subjects .
The sequential order of the GHSTs for suspected AGHD subjects (Group A-C) will be determined by stratified randomization; healthy control subjects (Group D) will be tested in the same sequence as the matched Group A subjects.
Serum concentrations of GH will be measured at pre-defined time points before and after GHST with macimorelin or insulin. A peak GH value below the GHST-specific cut-off value will be considered 'test positive'. The ITT will be considered as comparator (non-reference standard) to assess positive and negative agreement of both GHSTs, based on the predefined cut-off values.
Sponsor: AEterna Zentaris
Current Primary Outcome: Percent positive/ percent negative agreement of Macimorelin-GHST with ITT [ Time Frame: 28 days ]
Original Primary Outcome:
- Percent positive agreement of Macimorelin-GHST with ITT [ Time Frame: 28 days; upper limit for crossover interval between both GHSTs ]
- Percent negative agreement of Macimorelin-GHST with ITT [ Time Frame: 28 days ]Percent positive and negative agreement are defined as co-primary outcome measures.
Current Secondary Outcome:
- Percent overall agreement of Macimorelin-GHST with ITT [ Time Frame: 28 days ]
- Adverse events [ Time Frame: up to 28 days ]AEs during GHST and follow-up until second GHST or end-of-trial visit
- ECG [ Time Frame: 60 minutes ]Pre/post dose comparison of ECGs for both GHSTs
Original Secondary Outcome: Same as current
Information By: AEterna Zentaris
Dates:
Date Received: September 21, 2015
Date Started: September 2015
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017