Brief Title
Open Label Study of Octreotide Implant in Patients With Acromegaly
Official Title
An Open-Label Study to Evaluate the Pharmacokinetic and Pharmacodynamic Response of a Hydrated and Non-Hydrated 84mg Octreotide Implant in Patients With Acromegaly
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-hydrated, within 7 days of their Screening Visit. The octreotide implant was inserted subcutaneously in the inner aspect of their non-dominant arm under local anesthesia. Blood samples for the determination of insulin-like growth factor 1 (IGF-1), growth hormone (GH), and octreotide serum concentrations were collected at predetermined timepoints within the first 6 weeks after implantation.
Study Phase
Phase 2
Study Type
Interventional
Condition
Acromegaly
Intervention
octreotide acetate
Study Arms / Comparison Groups
One hydrated 84mg Octreotide implant
Description: hydrated implant
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
34
Start Date
February 2007
Completion Date
May 2007
Primary Completion Date
May 2007
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Administrative Informations
NCT ID
NCT00913055
Organization ID
01-07-000
Study Sponsor
Endo Pharmaceuticals
Study Sponsor
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Verification Date
July 2011