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NCT00109733 · ClinicalTrials.gov registry record · Phase 3

Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency

A Phase 3 study, sponsored by EMD Serono.

Completed
Registry status
Phase 3
Development phase
31
Enrollment target

NCT00109733 is a Phase 3 study that has completed, run by EMD Serono. The registered enrollment target is 31 participants.

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The verdict

NCT00109733, a Phase 3 study, has completed, sponsored by EMD Serono.

COMPLETED
Registry status
Phase 3
Development phase
31 participants
Enrollment target

Study Summary

The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.

Interventions

  • BIOLOGICAL recombinant human growth hormone

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2005-01
Est. Completion 2006-07
Phase Phase 3

Sponsor

EMD Serono

71 total trials

What the Registry Record Tells You About NCT00109733

The ClinicalTrials.gov registry entry for NCT00109733 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which recombinant human growth hormone is the first listed.

NCT00109733 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00109733 about?

NCT00109733 is a clinical study titled "Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency". The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.

What is the current status of trial NCT00109733?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2005-01. Estimated completion is 2006-07.

What interventions are being tested in trial NCT00109733?

The interventions under investigation include: recombinant human growth hormone (BIOLOGICAL).

Who is sponsoring clinical trial NCT00109733?

This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.