Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00396097 · ClinicalTrials.gov registry record · Phase 3
Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 316
- Enrollment target
NCT00396097: Completed Phase 3 study, sponsored by Pfizer.
NCT00396097 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 316 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00396097, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 316 participants
- Enrollment target
Study Summary
To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment
Primary Outcome
This was defined as an absolute difference between the 24-month height standard deviation score (SDS) and targeted 24-month height SDS (10th percentile (%), or -1.3 SDS). SDS indicates how similar the participant was to the reference population. These were calculated using 2000 Center for the Disease Control (CDC) growth reference tables (by age and gender).
Interventions
- DRUG Genotropin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2006-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT00396097 record still lists
NCT00396097 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 1 intervention - of which Genotropin is the first listed.
NCT00396097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00396097 about?
NCT00396097 is a clinical study titled "Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature". To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency o...
What is the current status of trial NCT00396097?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 316 participants. The study started on 2006-12. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00396097?
The interventions under investigation include: Genotropin (DRUG).
Who is sponsoring clinical trial NCT00396097?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00396097's enrollment target sits among peer trials
316 1090th of 2000 higher than 909 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04256317 · 316 participants · Phase 2
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
- NCT04787042 · 316 participants · Phase 1
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
- NCT04802759 · 316 participants · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
- NCT05464056 · 316 participants · NA
BUILT Family Lifestyle Program for Children with ADHD
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia