Phase 4
N=61
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
Short Stature Born Small for Gestational Age (SGA)
Bottom Line
View on ClinicalTrials.gov: NCT01859949 ↗Enrolled (actual)
61
Serious AEs
24.6%
Results posted
Mar 2016
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 27; 31; 10; 5 participant
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Genotropin (somatropin) (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
27; 31; 10; 5 | — |
| SECONDARY Height Velocity Standard Deviation Score (SDS) for Chronological Age |
2.782; 2.595; 1.812; 1.696; 1.480; 0.824 | — |
| SECONDARY Height Velocity |
7.83; 7.70; 6.88; 6.75; 6.68; 6.08 | — |
| SECONDARY Height SDS for Chronological Age |
-2.53; -2.17; -2.02; -1.70; -1.80; -1.53 | — |
| SECONDARY Height Velocity SDS for Bone Age |
2.586; 2.461; 1.503; 1.091; 1.196; 0.510 | — |
| SECONDARY Height SDS for Bone Age |
-1.19; -0.68; -1.15; -0.88; -1.20; -1.17 | — |
Summary
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
Eligibility Criteria
Inclusion Criteria
Children with short stature due to SGA who received treatment in the study GENASG-0021-002.
Exclusion Criteria
- Children who have any chronic disease requiring treatment with steroid hormone that may affect growth promotion including estrogen, androgen, anabolic hormone, and corticosteroids (except those for external use), and have received the treatment.
- Children who have received radiotherapy or chemotherapy.
- Children who have serious cardiac disease, renal disease, or hepatic disease.
- Children who have diabetes mellitus with a manifestation of abnormal glucose metabolism.
- Children who have serious chronic disease.
- Children who have malignant tumor.
- Children who are allergic to m-cresol.
Data sourced from ClinicalTrials.gov (NCT01859949). 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.