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NCT01840449 Clinical Trial

Somatuline Predictive Factors in Acromegaly and NET

Acromegaly Clinical Trial

— SOPRANo  

Official title:
Non-interventional, Observational Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel® (ATG) Treatment in Subjects With Either Acromegaly or Neuroendocrine Tumours (NET)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01840449
Other study ID # A-94-52030-240
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2012
Est. completion date May 2017

Study information
Verified date January 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours.

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date May 2017
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written informed consent (also mandatory in case of retrospective documentation of subject data)

- Diagnosis of acromegaly or NET with the intention to be treated with ATG or already on treatment with ATG

Exclusion Criteria:

- The subject has already been included in this study

- Participation in an interventional trial

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Somatuline Autogel® 60, 90 or 120 mg

Locations
Country Name City State
Austria University Hospital of Vienna Vienna
Germany ENDOC Hamburg
Switzerland University Hospital Basel Basel

Sponsors (1)
Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects) Baseline and 1 year
Secondary Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects) Baseline and 2 years
See also
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Completed NCT02012127 - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
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Terminated NCT00765323 - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly Phase 3
Completed NCT00531908 - Physiopathology of Sodium Retention in Acromegaly N/A
Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
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
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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
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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