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

International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00455884

Enrollment

546

Registered

2007-04-04

Start date

2006-06-30

Completion date

2011-12-31

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Disorders

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with Growth Hormone Deficiency * Patients treated with NutropinAq® * Patients having completed growth (fused epiphyses)

Exclusion criteria

* Active neoplasia * Pregnancy

Design outcomes

Primary

Measure	Time frame
Incidence of serious adverse events	when reported

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results