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Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Octreotide LAR
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, untreated, newly diagnosed, octreotide LAR

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: Newly diagnosed or previously untreated acromegalic patients Lack of suppression of growth hormone (GH) nadir to <1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test [OGTT]) Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender) Exclusion Criteria: Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass No evidence of pituitary adenoma on magnetic resonance imaging (MRI) Symptomatic cholelithiasis

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Mean GH and IGF-I at baseline, week 12, 24 and 48

    Secondary Outcome Measures

    Tumor volume at baseline, week 24 and 48
    Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
    Safety and tolerability at any time on treatment

    Full Information

    First Posted
    August 8, 2005
    Last Updated
    April 27, 2012
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00128232
    Brief Title
    Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients
    Official Title
    Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    August 2004 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    Brief Summary
    Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acromegaly
    Keywords
    Acromegaly, untreated, newly diagnosed, octreotide LAR

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Octreotide LAR
    Primary Outcome Measure Information:
    Title
    Mean GH and IGF-I at baseline, week 12, 24 and 48
    Secondary Outcome Measure Information:
    Title
    Tumor volume at baseline, week 24 and 48
    Title
    Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
    Title
    Safety and tolerability at any time on treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed or previously untreated acromegalic patients Lack of suppression of growth hormone (GH) nadir to <1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test [OGTT]) Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender) Exclusion Criteria: Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass No evidence of pituitary adenoma on magnetic resonance imaging (MRI) Symptomatic cholelithiasis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephan Petersenn, MD
    Organizational Affiliation
    Universität Duisburg-Essen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients

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