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Study in Polish Acromegalic Patients Treated With Somatuline Autogel

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01333384
First received: April 8, 2011
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Acromegaly

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean growth hormone (GH) levels [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Proportion of patients with GH levels below 1.0 microgram/liter [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333384

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

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01333384     History of Changes
Other Study ID Numbers: A-38-52030-739
Study First Received: April 8, 2011
Last Updated: February 26, 2013
Health Authority: Poland: Not required

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013