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standard GHST order randomized: clonidine - arginine for Human Growth Hormone Deficiency (DETECT Trial)

Phase 3

Waitlist Available

Research Sponsored by AEterna Zentaris

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up derived from cmax gh measurements collected in the time frame from 0 to 90 minutes after initial macimorelin ghst (visit 2 (day 0)) and gh adjudication status performed by the adjudication committee after visit 4 (between day 11 and day 58)).

Awards & highlights

DETECT Trial Summary

This trial will study whether the new macimorelin test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children.

Who is the study for?

This trial is for children aged 2 to less than 18 with suspected growth hormone deficiency who need a test to diagnose it. They must have had a height measurement in the past 6-18 months and not be on certain medications or have conditions that could affect the study.Check my eligibility

What is being tested?

The study tests macimorelin, a new substance to stimulate growth hormone release, against standard tests using arginine and clonidine. It aims to see if macimorelin is safe and effective for diagnosing growth hormone deficiency in kids.See study design

What are the potential side effects?

Potential side effects of macimorelin may include reactions similar to those seen with other hormonal stimulation tests such as nausea, headache, dizziness, changes in taste sensation or flushing. The safety profile will be closely monitored.

DETECT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ derived from cmax gh measurements collected in the time frame from 0 to 90 minutes after initial macimorelin ghst (visit 2 (day 0)) and gh adjudication status performed by the adjudication committee after visit 4 (between day 11 and day 58)).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~derived from cmax gh measurements collected in the time frame from 0 to 90 minutes after initial macimorelin ghst (visit 2 (day 0)) and gh adjudication status performed by the adjudication committee after visit 4 (between day 11 and day 58)).

This trial's timeline: 3 weeks for screening, Varies for treatment, and derived from cmax gh measurements collected in the time frame from 0 to 90 minutes after initial macimorelin ghst (visit 2 (day 0)) and gh adjudication status performed by the adjudication committee after visit 4 (between day 11 and day 58)). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the Receiver Operator Characteristic curve (ROC AUC) based on GH concentration during GHST following macimorelin administration

Secondary outcome measures

Overall agreement between the outcome of the macimorelin GHST and the combined outcome from the 2 standard GHSTs

Sensitivity for the macimorelin GHST

Specificity for the macimorelin GHST

DETECT Trial Design

2Treatment groups

Active Control

Group I: standard GHST order randomized: clonidine - arginineActive Control3 Interventions

At V2, all subjects will perform the macimorelin GHST and will be randomized 1:1 to the order of the clonidine and arginine GHSTs at V3 and V4. In this arm, those subjects will be presented which will have been randomized to the clonidine GHST at V3 and to the arginine GHST at V4. At V5 all subjects will perform the macimorelin GHST.

Group II: standard GHST order randomized: arginine - clonidineActive Control3 Interventions

At visit 2 (V2), all subjects will perform the macimorelin GHST and will be randomized 1:1 to the order of the clonidine and arginine GHSTs at visit 3 (V3) and visit 4 (V4). In this arm, those subjects will be presented which will have been randomized to the arginine GHST at V3 and the clonidine GHST at V4. At visit 5 (V5) all subjects will perform the macimorelin GHST.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Novo Nordisk A/SIndustry Sponsor

1,515 Previous Clinical Trials

2,415,312 Total Patients Enrolled

6 Trials studying Human Growth Hormone Deficiency

170 Patients Enrolled for Human Growth Hormone Deficiency

AEterna ZentarisLead Sponsor

41 Previous Clinical Trials

5,167 Total Patients Enrolled

Nicola K Ammer, MDStudy DirectorAEterna Zentaris

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research papers which compare the results of the standard GHST order of arginine and clonidine?

"The randomized standard order of GHST: arginine - clonidine was first trialled in 2021 at Azienda Ospedaliero-Universitaria Anna Meyer. So far, there have been 59 completed studies with 1 currently active trial. Many of these studies are conducted in Greenwood Village, Colorado."

Answered by AI

Is the combination of arginine and clonidine in GHST form safe for patients?

"Standard GHST order randomized: arginine - clonidine has received a safety score of 3 from our team at Power. This is because it is a Phase 3 trial, which means that there is both efficacy and safety data from multiple rounds of testing."

Answered by AI