Status:
COMPLETED
Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
25+ years
Phase:
PHASE3
Brief Summary
A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and...
Detailed Description
Six repeated applications of Lanreotide Autogel 120mg administered every 28, 42 or 56 days. For the first three injections, the interval depends on the Octreotide LAR dosage administered previously. T...
Eligibility Criteria
Inclusion
- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- The patient must have a documented diagnosis of active acromegaly and be adequately treated with a stable dose (10, 20 or 30 mg) of Octreotide LAR for at least 6 months immediately prior to study entry. A documented diagnosis of active acromegaly is defined as IGF-1 more than 30% higher than two Standard Deviations ( +2 SD) above the normal age and sex adjusted value (see Appendix 6) or GH level after OGTT (Oral Glucose Tolerance Test) \> 2ng/mL while not under drug treatment for acromegaly. For patients having undergone surgery or radiotherapy, this diagnosis must have been performed after the most recent surgical or radiation treatment
Exclusion
- The patient has had pituitary surgery (adenomectomy) within 6 months prior to study entry
- The patient has received stereotactic (LINAC, Gamma Knife) radiotherapy for acromegaly within three years or conventional radiotherapy for acromegaly within five years prior to study entry
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00444873
Start Date
January 1 2005
End Date
January 1 2008
Last Update
November 22 2019
Active Locations (1)
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1
Klinikum Innenstadt
Munich, Germany, 80336