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

January 11, 2019 updated by: Ipsen

International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy 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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

546

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Slough, Berkshire, United Kingdom, SL1 3XE
        • Ipsen Central Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients treated with NutropinAq in the specialised adult endocrinology centres in Germany, Italy, and UK.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Active neoplasia
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse events
Time Frame: when reported
when reported

Secondary Outcome Measures

Outcome Measure
Time Frame
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
when reported
Incidence of intercurrent cardiovascular events
Time Frame: when reported
when reported
Incidence of fractures
Time Frame: when reported
when reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (ESTIMATE)

April 4, 2007

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2-79-58035-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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