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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/NCT02020499
Registration number
NCT02020499
Ethics application status
Date submitted
19/12/2013
Date registered
25/12/2013
Date last updated
14/01/2019
Titles & IDs
Public title
Predictive Factors Study
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Scientific title
Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.
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Secondary ID [1]
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A-9B-52030-265
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Universal Trial Number (UTN)
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Trial acronym
TAPAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acromegaly
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Condition category
Condition code
Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
Acromegalic patients - Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)
Treatment: Drugs: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
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Assessment method [1]
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Timepoint [1]
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Baseline and 4 weeks
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Secondary outcome [1]
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Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
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Assessment method [1]
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Timepoint [1]
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Baseline, 1 year and 3 years
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Eligibility
Key inclusion criteria
- Diagnosis of Acromegaly.
- Males and females aged 18 years and older.
- Signed informed consent (patient must give consent to the collection of retrospective
data).
- Patients who have had surgery may enter the study 3 months post-surgery and evaluated
for the duration of the study.
- With the intention to be treated with ATG (decision to prescribe ATG made prior to
inclusion into the study) or already being treated with ATG.
- If already being treated with ATG:
Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data,
disease history including previous treatments, GH, IGF-1 levels at baseline and under
treatment as applicable).
- Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other
somatostatin analogues) for the treatment or symptom control of acromegaly.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- The subject has had radiotherapy in the last 5 years.
- The subject has had surgery in the last 3 months.
- The subject has already been included in this study.
- Participation in an interventional trial, or receiving experimental drug.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2015
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Sample size
Target
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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St Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [3]
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Royal Brisbane & Women's Hospital - Herston
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Recruitment hospital [4]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [5]
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St Vincent's Hospital - Fitzroy
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Recruitment hospital [6]
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The Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4006 - Herston
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Ipsen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a long term study to evaluate common therapeutic algorithms and possible predictive
parameters for Somatuline Autogel treatment in patients with Acromegaly.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02020499
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ipsen Medical Director
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Address
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Ipsen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02020499
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