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

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-03
• Study First Posted: 2007-04-04
• Study Completion: 2011-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

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 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 fractures	when reported
Incidence of intercurrent cardiovascular events	when reported

Trial Locations

Locations (1)

Ipsen Central Contact; 🇬🇧 Slough, Berkshire, United Kingdom