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Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

Primary Purpose

Acromegaly

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

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, Untreated, Newly diagnosed, Octreotide LAR, Pituitary surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newly diagnosed or previously untreated acromegalic patients Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of glucose (OGTT) 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 Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SMS995

    Arm Description

    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
    Quality of life and sleep apnea at baseline, week 12, 24 and 48
    Safety and tolerability at any time on treatment

    Full Information

    First Posted
    September 23, 2005
    Last Updated
    April 10, 2012
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00225979
    Brief Title
    Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
    Official Title
    Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    March 2005 (Actual)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

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

    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. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had 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, Pituitary surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SMS995
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Octreotide LAR
    Other Intervention Name(s)
    SMS995
    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
    Quality of life and sleep apnea 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
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed or previously untreated acromegalic patients Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of glucose (OGTT) 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 Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

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