Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | May 2000 |
| End Date: | January 2003 |
Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.
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 injections and after one year of treatment given at titrated doses.
after a single injection. Effectiveness and safety were then also assessed following four
fixed-dose injections and after one year of treatment given at titrated doses.
Inclusion Criteria:
- documentation of a diagnosis of active acromegaly based on either of the following
definitions:
1. 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
2. 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 Criteria:
- 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
We found this trial at
12
sites
733 North Broadway
Baltimore, Maryland 21205
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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