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Trial registered on ANZCTR


Registration number
ACTRN12608000606381
Ethics application status
Approved
Date submitted
30/10/2008
Date registered
4/12/2008
Date last updated
3/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Observational study comparing the safety and tolerability of Somatuline (Registered trade mark) Autogel (Registered trade mark) injected by Health Care Professionals and patients who inject at home for the treatment of acromegaly.
Scientific title
An observational, multicentre, open label non interventional programme to assess the long-term safety and efficacy of Somatuline (registered trade mark) Autogel (registered trade mark) in the treatment of acromegaly when administered by patients or their partners ("Home Injection Group") or administered by healthcare professionals.
Secondary ID [1] 740 0
A-9B-52030-219
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 3901 0
Condition category
Condition code
Metabolic and Endocrine 4101 4101 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Somatuline Autogel for acromegaly. This will be administered subcutaneously at a dose and frequency clinically indicated. The dose and frequency for Somatuline Autogel will vary for participants depending on the physicians discretion. The duration of the observation will be up to 4 years. Both the health care professional group and home injection group will be exposed to the therapy. The home injection group will inject themselves or have a partner/carer inject.
Intervention code [1] 3702 0
Not applicable
Comparator / control treatment
Health Care Professional injection will be the comparator group. These patients will be injected with Somatuline Autogel by a health care professional.
Control group
Active

Outcomes
Primary outcome [1] 4993 0
Safety and Local Tolerability of Somatuline Autogel assessed by question to the patient on the incidence of untoward effects. This will be recorded in an electronic case report form (eCRF).
Timepoint [1] 4993 0
The primary assessment question will be asked prior to each administration of Somatuline Autogel over the 4 year period
Secondary outcome [1] 8433 0
Efficacy of Somatuline Autogel measured by the completion of survey (eCRF) by treating physician.
Timepoint [1] 8433 0
Assessed prior to each administration of Somatuline Autogel over the 4 year period
Secondary outcome [2] 8434 0
Home Injection Training Requirements measured by the completion of survey (eCRF) by treating physician.
Timepoint [2] 8434 0
Assessed prior to each administration of Somatuline Autogel over the 4 year period
Secondary outcome [3] 8435 0
Acceptability of Home Injection measured by the completion of survey (eCRF) by treating physician.
Timepoint [3] 8435 0
Assessed prior to each administration of Somatuline Autogel over the 4 year period

Eligibility
Key inclusion criteria
Patients on a stable dose of Somatuline Autogel for at least 4 months and with a diagnosis of Acromegaly.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are pregnant or breastfeeding.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1290 0
2145
Recruitment postcode(s) [2] 1291 0
3065
Recruitment postcode(s) [3] 1292 0
5041
Recruitment postcode(s) [4] 1293 0
4102
Recruitment postcode(s) [5] 1294 0
2305

Funding & Sponsors
Funding source category [1] 4093 0
Commercial sector/Industry
Name [1] 4093 0
Ipsen Pty Ltd
Address [1] 4093 0
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, Victoria, Australia, 3150
Country [1] 4093 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ipsen Pty Ltd
Address
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, Victoria, Australia, 3150
Country
Australia
Secondary sponsor category [1] 3745 0
None
Name [1] 3745 0
Address [1] 3745 0
Country [1] 3745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6162 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 6162 0
PO Box 2900
Fitzroy Vic 3065
Ethics committee country [1] 6162 0
Australia
Date submitted for ethics approval [1] 6162 0
24/09/2008
Approval date [1] 6162 0
20/01/2009
Ethics approval number [1] 6162 0

Summary
Brief summary
This study will compare the safety and tolerability of a treatment for acromegaly in two groups: one group is injected by a health care professional the other group will inject themselves or have a carer/partner inject.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29083 0
Dr Mark McLean
Address 29083 0
Diabetes and Endocrinology,
Westmead Hospital,
Hawkesbury Road,
Westmead, NSW, 2145
Country 29083 0
Australia
Phone 29083 0
+61 2 9851 6073
Fax 29083 0
Email 29083 0
mmclean@med.usyd.edu.au
Contact person for public queries
Name 12240 0
Mr Jay Dharma
Address 12240 0
Ipsen Pty Ltd.,
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, Victoria, Australia, 3150
Country 12240 0
Australia
Phone 12240 0
+61 3 85448100
Fax 12240 0
Email 12240 0
jay.dharma@ipsen.com
Contact person for scientific queries
Name 3168 0
Dr Dr Monica de Abadal
Address 3168 0
Ipsen Pty Ltd.,
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, Victoria, Australia, 3150
Country 3168 0
Australia
Phone 3168 0
+61 3 85448100
Fax 3168 0
Email 3168 0
monica.deabadal.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary