Status:
TERMINATED
Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Acromegaly
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.
Detailed Description
This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1 to Week 24), and the Extension Phase (Post Week 24 to Week 48). Primary efficacy and safety will be determin...
Eligibility Criteria
Inclusion
- Male and female patients with acromegaly
- Confirmed diagnosis of a growth hormone-secreting tumor
- Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening
- Must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: IGF-1 \< 20% above the upper limit of normal age and sex-adjusted levels and GH ≤ 2.5 ng/mL
Exclusion
- Patients with pituitary surgery less than 3 months prior to screening
- Uncontrolled diabetes defined as having a fasting glucose \> 150 mg/dl and HbA1c \>= 9%
- Symptomatic cholelithiasis
- Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial
- Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before Screening
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00765323
Start Date
September 1 2008
End Date
June 1 2011
Last Update
September 27 2013
Active Locations (47)
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1
Stanford University Medical Center - Stanford Hospitals and Clinics
Palo Alto, California, United States, 94304
2
University of Colorado - Veterans Administration Medical Center - Endocrinology
Denver, Colorado, United States, 80220
3
Galiz Research
Miami, Florida, United States, 33145
4
The University of Illinois at Chicago
Chicago, Illinois, United States, 60608