Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00184730 | Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) | PHASE3 | COMPLETED | 86 | — | — | Nov 1, 2004 | Sep 1, 2006 | Nov 17, 2016 | 1 | Japan |
| NCT00184743 | Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) | PHASE3 | COMPLETED | 112 | — | — | Dec 6, 2003 | Dec 28, 2005 | Feb 28, 2017 | 1 | Japan |
| NCT00519558 | Growth Hormone Deficiency in Adults (GHDA) | PHASE3 | COMPLETED | 121 | — | — | May 31, 2003 | Jan 24, 2005 | Feb 28, 2017 | 1 | Japan |
| NCT00102817 | Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children | PHASE3 | COMPLETED | 149 | — | — | May 1, 2003 | Dec 1, 2006 | Jan 18, 2017 | 27 | United States |
| NCT00184678 | Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency | PHASE3 | COMPLETED | 161 | — | — | Feb 1, 2002 | Jul 1, 2006 | Jan 13, 2017 | 30 | Australia, Austria +10 |
| NCT01502124 | Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency | PHASE3 | COMPLETED | 78 | — | — | May 8, 2001 | Mar 5, 2003 | Feb 28, 2017 | 21 | United States |
| NCT01563926 | Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency | PHASE3 | COMPLETED | 168 | — | — | Oct 23, 2000 | Oct 10, 2002 | Feb 27, 2017 | 6 | Israel |
| NCT00262249 | Effect of Growth Hormone in Children With Growth Hormone Deficiency | PHASE3 | COMPLETED | 173 | — | — | Aug 1, 2000 | May 1, 2004 | Jan 18, 2017 | 40 | United States |
| NCT00931476 | A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin | PHASE1 | COMPLETED | 86 | — | — | Apr 6, 2000 | Jun 8, 2000 | Feb 27, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Lyophilized | ACTIVE_COMPARATOR | - |
| Liquid | EXPERIMENTAL | - |
| Somatropin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| somatropin | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: * Subjects who completed GHLiquid-1519. * If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be exclu...