Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing
This study is enrolling participants by invitation only.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01110928
First received: April 19, 2010
Last updated: March 19, 2013
Last verified: February 2013
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Purpose
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).
| Condition | Intervention |
|---|---|
|
Foetal Growth Problem Small for Gestational Age |
Drug: somatropin |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Number and type of suspected serious adverse drug reactions (SADRs) during the study period [ Time Frame: evaluated binannually for 9 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of glucose intolerance events during the study period [ Time Frame: evaluated biannually for 9 years ] [ Designated as safety issue: Yes ]
- Adult height [ Time Frame: Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 360 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2018 |
| Estimated Primary Completion Date: | October 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Norditropin® |
Drug: somatropin
Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with SGA short stature that are still growing, who will either receive Norditropin® (somatropin) treatment or completed the GHLIQUID-1517 trial.
Criteria
Inclusion Criteria:
- Participation in the GHLIQUID-1517 trial
- Patients with SGA (small for gestational age) short stature that are still growing
Exclusion Criteria:
- Known or suspected allergy to study product(s) or related products
- Diabetes Mellitus
- Patients with malignant tumor(s)
- Pregnant or likely to get pregnant
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01110928 History of Changes |
| Other Study ID Numbers: | GH-3812, U1111-1114-6280, JapicCTI-101123 |
| Study First Received: | April 19, 2010 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Japan: Pharmaceuticals and medical devices agency (PMDA) |
Additional relevant MeSH terms:
|
Dwarfism Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Genetic Diseases, Inborn Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013