Growth Hormone Disorders Clinical Trial
Official title:
International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency
NCT number | NCT00455884 |
Other study ID # | 2-79-58035-006 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2006 |
Est. completion date | December 2011 |
Verified date | January 2019 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom
Status | Completed |
Enrollment | 546 |
Est. completion date | December 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with Growth Hormone Deficiency - Patients treated with NutropinAq® - Patients having completed growth (fused epiphyses) Exclusion Criteria: - Active neoplasia - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Ipsen Central Contact | Slough | Berkshire |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of serious adverse events | when reported | ||
Secondary | Incidence of targeted adverse events, including adrenal insufficiency, arthritis, carpal tunnel syndrome, intracranial hypertension, new onset and recurrence of leukemia & tumor, pancreatitis, peripheral edema requiring medical intervention and death | when reported | ||
Secondary | Incidence of intercurrent cardiovascular events | when reported | ||
Secondary | Incidence of fractures | when reported |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00455728 -
A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders
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