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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01471405
First received: November 10, 2011
Last updated: March 27, 2014
Last verified: March 2014
  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 ] [ Designated as safety issue: No ]
  • Proportion of patients receiving other medical treatments [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with at least one pituitary surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01471405     History of Changes
Other Study ID Numbers: 8-79-52030-742
Study First Received: November 10, 2011
Last Updated: March 27, 2014
Health Authority: France: French Data Protection Authority
United Kingdom: National Health Service
Italy: The Italian Medicines Agency
Czech Republic: State Institute for Drug Control
Turkey: Ethics Committee
Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 21, 2014