Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00216398




Registration number
NCT00216398
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
16/08/2019

Titles & IDs
Public title
Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
Scientific 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
Secondary ID [1] 0 0
A-9B-52030-159
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
The percentage of patients with normalised IGF-1 compared to the baseline visit.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Change in the GH values compared to the baseline (Week 0) visit.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Change in the IGF-1 values compared to the baseline (Week 0) visit.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Change in serum lanreotide levels compared to the baseline (Week 0) visit.
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Change in the serum octreotide levels compared to the baseline visit.
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Timepoint [8] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/06/2006
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Study Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00216398