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One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471405
First Posted: November 15, 2011
Last Update Posted: March 28, 2014
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.
Information provided by (Responsible Party):
Ipsen
  Purpose
This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.

Condition
Acromegaly

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Non-interventional Study Evaluating Treatment Adaption During a One Year Follow-up After Completion of the 2-79-52030-207 Study in a Group of Acromegalic Patients With Macroadenoma Who Received 12 Injections of Lanreotide Autogel® 120 mg

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Proportion of patients maintained on medical treatment with lanreotide Autogel [ Time Frame: 1 year ]
  • Proportion of patients receiving other medical treatments [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Proportion of patients with at least one pituitary surgery [ Time Frame: 1 year ]

Enrollment: 54
Study Start Date: January 2012
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

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
Outpatients
Criteria

Inclusion Criteria:

  • Completed the 2-79-52030-207 study and received 12 injections of lanreotide Autogel 120 mg, regardless of efficacy at the end of this period.
  • Subject or in case of subject's death next of kin having given their written informed consent prior to collection of the data by the sponsor (if locally required)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01471405


Locations
Czech Republic
III. Interní klinika Karlova Univerzita
Praha 2, Czech Republic
France
CHU de Rouen
Bois Guillaume, France, 76230
Groupement hôspitalier est Federation d'endocrinologie.
Bron, France
CHU Michallon
Grenoble, France
Hôpital Claude Huriez
Lille, France
CHU Timone
Marseille, France
Hôpital Bicêtre
Paris, France
Hôpital Haut Leveque
Pessac, France
CHU de Reims
Reims, France
Hôpital Larrey
Toulouse, France
Germany
Universität Duisburg-Essen
Essen, Germany
Klinikum der Johann Wolfgang, Goethe-Universität
Frankfurt, Germany
Italy
Università Federico II di Napoli
Napoli, Italy
Università Cattolica del Sacro Cuore
Roma, Italy
Turkey
İstanbul Universitesi, Cerrahpaşa Tıp Fakültesi
Istanbul, Turkey
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Christie Hospital
Manchester, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Antoine Clermont, M.D. Ipsen
  More Information

Additional Information:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01471405     History of Changes
Other Study ID Numbers: 8-79-52030-742
First Submitted: November 10, 2011
First Posted: November 15, 2011
Last Update Posted: March 28, 2014
Last Verified: March 2014

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