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OpenTrials
Completed

NCT Number: NCT00455884

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

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

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Key information

Conditions

Growth Hormone Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Ipsen Central Contact

Slough, Berkshire, SL1 3XE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Active neoplasia
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Incidence of serious adverse events

    Time frame: when reported

Secondary outcomes

  1. 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

    Time frame: when reported

  2. Incidence of intercurrent cardiovascular events

    Time frame: when reported

  3. Incidence of fractures

    Time frame: when reported

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2011
First posted
Apr 4, 2007
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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