A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency
Completed
- Conditions
- Growth Hormone Disorders
- Registration Number
- NCT00455884
- Lead Sponsor
- Ipsen
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 546
Inclusion Criteria
- Patients with Growth Hormone Deficiency
- Patients treated with NutropinAq®
- Patients having completed growth (fused epiphyses)
Exclusion Criteria
- Active neoplasia
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of serious adverse events when reported
- Secondary Outcome Measures
Name Time Method Incidence of fractures when reported 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 Incidence of intercurrent cardiovascular events when reported
Trial Locations
- Locations (1)
Ipsen Central Contact
🇬🇧Slough, Berkshire, United Kingdom