Status:
COMPLETED
Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatme...
Eligibility Criteria
Inclusion
- The subject has given written informed consent prior to any study-related procedures
- The subject is male or female and is over 18 years of age
- The subject must have had documentation supporting the diagnosis of acromegaly, based on elevated IGF-1 and/or GH levels
- The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF 1 levels for two consecutive measurements (at least two months apart) preceding study entry
- If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period
Exclusion
- The subject has received radiation therapy to the pituitary gland before study entry
- The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure
- The subject has received a growth hormone receptor antagonist (pegvisomant) therapy within three months before study entry
- The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than lanreotide 120 mg, during the course of the study
- The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00701363
Start Date
October 1 2008
End Date
May 1 2013
Last Update
January 29 2019
Active Locations (44)
Enter a location and click search to find clinical trials sorted by distance.
1
Universidade Federal do Rio de Janeiro - Department of Internal Medicine - Section of Endocrinology - Neuroendocrine Research Center
Rio de Janeiro, Brazil
2
Hospital das Clínicas de São Paulo - Internal Medicine - Neuroendocrine Unit - Division of Endocrinology and Metabolism
São Paulo, Brazil
3
Arhus University Hospital - Department of Medicinsk AVd M
Arhus C, Denmark, DK 8000
4
Righospitalet - University Department of Endocrinology & Internal Medicine P
Copenhagen, Denmark, DK-2100