One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma
This study has been completed.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01471405
First received: November 10, 2011
Last updated: March 27, 2014
Last verified: March 2014
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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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01471405
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 |
ClinicalTrials.gov processed this record on March 01, 2015