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
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Click here to add this to my saved trials
Click here to add this to my saved trials