Study in Polish Acromegalic Patients Treated With Somatuline Autogel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01333384
Recruitment Status : Completed
First Posted : April 12, 2011
Last Update Posted : August 22, 2014
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.

Condition or disease

Study Type : Observational
Actual Enrollment : 150 participants
Official Title: A Non-Interventional Retrospective (12 Months) and Prospective (at Least 24 Months) Resource Utilization Study, in the Population of Polish Acromegalic Patients Treated With Somatuline Autogel at Normal (4 Weeks) or Extended (6 or 8 Weeks) Dosing Interval
Study Start Date : October 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Percentage variation of Insulin-like growth factor-1 (IGF-1) levels [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Mean growth hormone (GH) levels [ Time Frame: 24 months ]
  2. Proportion of patients with GH levels below 1.0 microgram/liter [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Observation of 150 patients out of 500 routinely treated with somatostatin analogues in Poland

Inclusion Criteria:

  • Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg
  • Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available

Exclusion Criteria:

  • Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01333384

Ipsen Central Contact
Warsaw, Poland
Sponsors and Collaborators
Study Director: Andrzej Suwala, M.D. PhD. Ipsen

Responsible Party: Ipsen Identifier: NCT01333384     History of Changes
Other Study ID Numbers: A-38-52030-739
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Antineoplastic Agents