Status:
COMPLETED
Open Label Study of Octreotide Implant in Patients With Acromegaly
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of treatment.
Detailed Description
An open-label, randomized, multi-center, parallel-group, Phase I/II study conducted in 30 male and female patients with acromegaly. Eligible patients received 1 implant, either hydrated or non-hydrate...
Eligibility Criteria
Inclusion
- Male and female patients with acromegaly
- Must be at least 18 years old
- Confirmed diagnosis of a growth hormone -secreting tumor
- Must be either a full or partial responder to octreotide demonstrated by historical laboratory values
Exclusion
- Women who are pregnant, lactating or of child-bearing potential who are not practicing a medically acceptable method of birth control
- Patients with liver disease
- Patients with symptomatic cholelithiasis
- Patients receiving radiotherapy for their pituitary tumor at any time before Screening
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00913055
Start Date
February 1 2007
End Date
May 1 2007
Last Update
July 14 2011
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