Acromegaly Clinical Trial
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
| NCT number | NCT01471405 |
| Other study ID # | 8-79-52030-742 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2012 |
| Est. completion date | August 2013 |
| Verified date | January 2019 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | August 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | III. Interní klinika Karlova Univerzita | Praha 2 | |
| France | CHU de Rouen | Bois Guillaume | |
| France | 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 | |
| Germany | Universität Duisburg-Essen | Essen | |
| Germany | Klinikum der Johann Wolfgang, Goethe-Universität | Frankfurt | |
| Italy | Università Federico II di Napoli | Napoli | |
| Italy | Università Cattolica del Sacro Cuore | Roma | |
| Turkey | Istanbul Universitesi, Cerrahpasa Tip Fakültesi | Istanbul | |
| United Kingdom | Aberdeen Royal Infirmary | Aberdeen | |
| United Kingdom | Christie Hospital | Manchester | |
| United Kingdom | Derriford Hospital | Plymouth |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
Czechia, France, Germany, Italy, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients maintained on medical treatment with lanreotide Autogel | 1 year | ||
| Primary | Proportion of patients receiving other medical treatments | 1 year | ||
| Secondary | Proportion of patients with at least one pituitary surgery | 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06344650 -
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
|
||
| Active, not recruiting |
NCT02092129 -
Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.
|
N/A | |
| Completed |
NCT02012127 -
Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
|
||
| Active, not recruiting |
NCT01265121 -
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
|
N/A | |
| Terminated |
NCT00765323 -
Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
|
Phase 3 | |
| Completed |
NCT00500227 -
Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
|
||
| Completed |
NCT00531908 -
Physiopathology of Sodium Retention in Acromegaly
|
N/A | |
| Completed |
NCT01278342 -
Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients
|
Phase 4 | |
| Active, not recruiting |
NCT01809808 -
A Prospective Study of Outcome After Therapy for Acromegaly
|
||
| Completed |
NCT00145405 -
Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction
|
Phase 4 | |
| Completed |
NCT00210457 -
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
|
Phase 3 | |
| Recruiting |
NCT05401084 -
Diet in the Management of Acromegaly
|
N/A | |
| Recruiting |
NCT00005100 -
Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
|
N/A | |
| Completed |
NCT00521300 -
Preoperative Octreotide Treatment of Acromegaly
|
Phase 4 | |
| Completed |
NCT03548415 -
Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
|
Phase 2 | |
| Not yet recruiting |
NCT04066569 -
Reproducibility and Utility of OGTT in Acromegaly
|
N/A | |
| Not yet recruiting |
NCT05298891 -
Hypoproteic Diet in Acromegaly
|
N/A | |
| Recruiting |
NCT04520646 -
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
|
N/A | |
| Not yet recruiting |
NCT04529356 -
The TMS Treatment for Postoperative Headache in GH Tumor
|
N/A | |
| Active, not recruiting |
NCT03252353 -
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
|
Phase 3 |