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Open Label Study of Octreotide Implant in Patients With Acromegaly

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
octreotide acetate
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring S-LAR, Octreotide, Implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    One hydrated 84mg Octreotide implant

    One non-hydrated 84mg Octreotide implant

    Arm Description

    hydrated implant

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 26, 2009
    Last Updated
    July 13, 2011
    Sponsor
    Endo Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00913055
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Endo Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acromegaly
    Keywords
    S-LAR, Octreotide, Implant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    One hydrated 84mg Octreotide implant
    Arm Type
    Experimental
    Arm Description
    hydrated implant
    Arm Title
    One non-hydrated 84mg Octreotide implant
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    octreotide acetate
    Intervention Description
    subcutaneous implant

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Open Label Study of Octreotide Implant in Patients With Acromegaly

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