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

January 10, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha 2, Czechia
        • III. Interní klinika Karlova Univerzita
  • France
      • Bois Guillaume, France, 76230
        • CHU de Rouen
      • Bron, France
        • Groupement hôspitalier est Federation d'endocrinologie.
      • Grenoble, France
        • CHU Michallon
      • Lille, France
        • Hôpital Claude Huriez
      • Marseille, France
        • CHU Timone
      • Paris, France
        • Hôpital Bicêtre
      • Pessac, France
        • Hôpital Haut Levêque
      • Reims, France
        • CHU de Reims
      • Toulouse, France
        • Hôpital Larrey
  • Germany
      • Essen, Germany
        • Universität Duisburg-Essen
      • Frankfurt, Germany
        • Klinikum der Johann Wolfgang, Goethe-Universität
  • Italy
      • Napoli, Italy
        • Universita Federico II di Napoli
      • Roma, Italy
        • Universita Cattolica del Sacro Cuore
  • Turkey
      • Istanbul, Turkey
        • İstanbul Universitesi, Cerrahpaşa Tıp Fakültesi
  • United Kingdom
      • Aberdeen, United Kingdom
        • Aberdeen Royal Infirmary
      • Manchester, United Kingdom
        • Christie Hospital
      • Plymouth, United Kingdom
        • Derriford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients maintained on medical treatment with lanreotide Autogel
Time Frame: 1 year
1 year
Proportion of patients receiving other medical treatments
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with at least one pituitary surgery
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 15, 2011

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8-79-52030-742

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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