Back to resultsLanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Lanreotide (Autogel formulation)
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring acromegaly, growth hormone
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of acromegaly The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L. The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry Life expectancy of at least 2 years Exclusion Criteria: Adenectomy within past 6 months, or likely during study period Radiotherapy for acromegalic disease within 1 year, or likely during study period Unstable concomitant dopamine agonist therapy
Sites / Locations
- Westmead Hospital
Outcomes
Primary Outcome Measures
The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.
Secondary Outcome Measures
The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
The percentage of patients with normalised IGF-1 compared to the baseline visit.
Change in the GH values compared to the baseline (Week 0) visit.
Change in the IGF-1 values compared to the baseline (Week 0) visit.
Change in serum lanreotide levels compared to the baseline (Week 0) visit.
Change in the serum octreotide levels compared to the baseline visit.
Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00216398
Brief Title
Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
Official Title
A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 22, 2006 (Actual)
Study Completion Date
June 22, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
acromegaly, growth hormone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lanreotide (Autogel formulation)
Primary Outcome Measure Information:
Title
The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.
Secondary Outcome Measure Information:
Title
The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
Title
The percentage of patients with normalised IGF-1 compared to the baseline visit.
Title
Change in the GH values compared to the baseline (Week 0) visit.
Title
Change in the IGF-1 values compared to the baseline (Week 0) visit.
Title
Change in serum lanreotide levels compared to the baseline (Week 0) visit.
Title
Change in the serum octreotide levels compared to the baseline visit.
Title
Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Title
Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of acromegaly
The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.
The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
Life expectancy of at least 2 years
Exclusion Criteria:
Adenectomy within past 6 months, or likely during study period
Radiotherapy for acromegalic disease within 1 year, or likely during study period
Unstable concomitant dopamine agonist therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Study Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
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