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NCT02968004 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
A Phase 3 study, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 224
- Enrollment target
NCT02968004: Completed Phase 3 study, sponsored by OPKO Health.
NCT02968004 is a Phase 3 study that has completed, run by OPKO Health. The registered enrollment target is 224 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02968004, a Phase 3 study, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 224 participants
- Enrollment target
Study Summary
This is an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.
Primary Outcome
Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
Interventions
- DRUG Somatropin
- DRUG MOD-4023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2016-12 |
| Est. Completion | 2024-05 |
| Phase | Phase 3 |
What the finished NCT02968004 record still lists
NCT02968004 is an interventional study that assigns participants to a tested intervention. The registered 224 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 (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Somatropin is the first listed.
NCT02968004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02968004 about?
NCT02968004 is a clinical study titled "Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children". This is an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.
What is the current status of trial NCT02968004?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 224 participants. The study started on 2016-12. Estimated completion is 2024-05.
What interventions are being tested in trial NCT02968004?
The interventions under investigation include: Somatropin (DRUG), MOD-4023 (DRUG).
Who is sponsoring clinical trial NCT02968004?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02968004's enrollment target sits among peer trials
224 1317th of 2000 higher than 684 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
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