Brief Title
Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
Official Title
Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly
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 determined from the Primary Treatment Phase. Eligible patients will be randomized during the Primary Treatment Phase; in a 3 to 1 ratio to receive 6 months of open-label treatment with either the 84 mg octreotide implant or monthy Injections of S-LAR. Each patient in this study will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits. All patients who complete the Primary Treatment Phase and who continue to meet eligibility criteria will be offered the opportunity to enter the Extension Phase; patients entering the Extension Phase will be treated with an octreotide implant for 6 months.During the Extension Phase, patients will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments
Condition
Acromegaly
Intervention
Octreotide Implant
Study Arms / Comparison Groups
1
Description: 84 mg octreotide implant for 6 months
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
169
Start Date
September 2008
Completion Date
June 2011
Primary Completion Date
February 2011
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Czech Republic
Location Countries
Czech Republic
Administrative Informations
NCT ID
NCT00765323
Organization ID
IP107-001
Responsible Party
Sponsor
Study Sponsor
Endo Pharmaceuticals
Study Sponsor
, ,
Verification Date
September 2013