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Study in Polish Acromegalic Patients Treated With Somatuline Autogel

This study has been completed.
Information provided by (Responsible Party):
Ipsen Identifier:
First received: April 8, 2011
Last updated: August 21, 2014
Last verified: August 2014
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.


Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Ipsen:

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

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

Enrollment: 150
Study Start Date: October 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01333384

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

Responsible Party: Ipsen Identifier: NCT01333384     History of Changes
Other Study ID Numbers: A-38-52030-739
Study First Received: April 8, 2011
Last Updated: August 21, 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 processed this record on August 21, 2017