DRUG
Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
Status
Completed
Phase
Phase 4
Enrollment
8
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 22, 2005
Study start
Jun 2004
Primary completion
Jun 22, 2006
Study completion
Jun 22, 2006
Results posted
Not reported
Registry updated
Aug 16, 2019
Outcomes
What the study measures.
Primary outcomes
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 outcomes
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
Australia. Showing up to 24 locations stored in the fast local snapshot.
Westmead Hospital
Westmead, New South Wales, Australia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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