A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455884
• Other study ID #: 2-79-58035-006
• Status: Completed
• Start date: June 2006
• Est. completion date: December 2011

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: December 2011
• 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

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Disorders

Locations

Country	Name	City	State
United Kingdom	Ipsen Central Contact	Slough	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

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