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NCT00140413 · ClinicalTrials.gov registry record · Phase 4
Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
A Phase 4 study of Growth Hormone Deficiency and Hypopituitarism, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00140413: Completed Phase 4 study of Growth Hormone Deficiency and Hypopituitarism, sponsored by Children's Hospital Los Angeles.
NCT00140413 is a Phase 4 study of Growth Hormone Deficiency and Hypopituitarism that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 20 participants, below the 386-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00140413, a Phase 4 study of Growth Hormone Deficiency and Hypopituitarism, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Hypotheses: 1. The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular, among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is commonly thought. 2. Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes. Aims: 1. Determine the prevalence and types of endocrinopathies in children diagnosed with ONH. 2. Correlate endocrine outcome with radiographic, ocular, and developmental findings in children with ONH. 3. Examine the effect of GH treatment on growth and obesity in children with ONH, GH-deficiency, and either subnormal or normal growth compared to children with ONH that are not GH-deficient. 4. Compare growth outcomes between children with isolated GH-deficiency and those with multiple hormone deficiencies.
Primary Outcome
Primary outcome measures included change in stature, weight, BMI, and weight-for-stature z-scores over the course of the study. Z-score indicates how many standard deviations an element is from the mean. It is calculated as z = (x - µ) σ, where µ is the mean of the population, and σ is the standard deviation of the population. A positive z-score indicates a datum above the mean, while a negative z-score indicates a datum below the mean. All z-scores were obtained using Epi Info ™ 3.5.4. (Centers
Conditions Studied
Interventions
- DRUG Nutropin AQ
Study Locations (1)
California
- Childrens Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2004-12 |
| Est. Completion | 2014-02 |
| Phase | Phase 4 |
What the finished NCT00140413 record still lists
NCT00140413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 386-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Growth Hormone Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Nutropin AQ is the first listed.
NCT00140413 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00140413 about?
NCT00140413 is a clinical study titled "Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia". Hypotheses: 1. The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular, among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is commonly thought. 2. Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes. Aims: 1...
What is the current status of trial NCT00140413?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2004-12. Estimated completion is 2014-02.
What conditions does trial NCT00140413 study?
This clinical trial studies the following conditions: Growth Hormone Deficiency, Hypopituitarism, Septo-Optic Dysplasia.
What interventions are being tested in trial NCT00140413?
The interventions under investigation include: Nutropin AQ (DRUG).
Who is sponsoring clinical trial NCT00140413?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00140413 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00140413's enrollment target sits among peer trials
20 13th of 16 higher than 3 of 16 other Growth Hormone Deficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Growth Hormone Deficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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