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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Lanreotide (Autogel formulation)

Treatment: Drugs: Lanreotide (Autogel formulation)
Intervention code [1] 0 0
Treatment: Drugs
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00216398
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