N/A
Completed N=230
Drug Use Investigation of Somatropin for GHD-ADULTS.
Dwarfism, Growth Hormone Deficiency
Source: ClinicalTrials.gov NCT00601419 ↗
Enrolled (actual)
230
Serious AEs
4.4%
Results posted
Feb 2014
Primary outcomePrimary: Number of Participants With Treatment Related Adverse Events. — 29 participants
Summary
Post marketing drug use investigation of Genotropin for GHD-ADULTS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Related Adverse Events. |
29 | — |
| PRIMARY Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. |
8 | — |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age. |
24; 5 | =0.556 |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin by Gender. |
13; 16 | =0.845 |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency. |
17; 12 | =0.038 sig |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease. |
17; 12 | =0.013 sig |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin. |
23; 4; 0; 1 | =0.037 sig |
| PRIMARY Proportion of Participants Achieving Clinical Efficacy. |
185; 14; 0 | — |
| PRIMARY Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age. |
165; 20 | =0.019 sig |
| PRIMARY Proportion of Participants Achieving Clinical Efficacy by Gender. |
86; 99 | =1.000 |
| PRIMARY Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency. |
116; 66 | =0.037 sig |
Eligibility Criteria
Inclusion Criteria
The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)".
Exclusion Criteria
Patients not administered Somatropin.
Data sourced from ClinicalTrials.gov (NCT00601419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.