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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
A-9B-52030-265
Universal Trial Number (UTN)
Trial acronym
TAPAS
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Timepoint [1] 0 0
Baseline and 4 weeks
Secondary outcome [1] 0 0
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Timepoint [1] 0 0
Baseline, 1 year and 3 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [6] 0 0
The Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4006 - Herston
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02020499
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical 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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02020499