Status:
COMPLETED
Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injectio...
Eligibility Criteria
Inclusion
- documentation of a diagnosis of active acromegaly based on either of the following definitions:
- the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level \>5ng/mL at visit 1; or
- the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH \>3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a)
Exclusion
- receipt of radiotherapy for acromegaly within 3 years
- pituitary surgery within 3 months prior to visit 1
- prior receipt of lanreotide autogel or GH antagonist
- anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period
- known hypersensitivity to any of the test materials or related compounds
- clinically significant renal or hepatic abnormalities
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2003
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00234572
Start Date
May 1 2000
End Date
January 3 2003
Last Update
August 2 2019
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Baptist Health System Inc
Birmingham, Alabama, United States, 35213
2
Pituitary Center
Los Angeles, California, United States, 90048
3
Northwestern Medical Facility
Chicago, Illinois, United States, 60611
4
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287