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Trial registered on ANZCTR


Registration number
ACTRN12609000226202
Ethics application status
Approved
Date submitted
21/04/2009
Date registered
5/05/2009
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 neuroendocrine tumours.
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 neuroendocrine tumours when administered by patients or their partners ("Home Injection Group") or administered by healthcare professionals.
Secondary ID [1] 846 0
A-9B-52030-220. Ipsen Pty Ltd
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Tumours 4636 0
Condition category
Condition code
Cancer 4938 4938 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Somatuline Autogel for neuroendocrine tumours. 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] 4397 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] 5787 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] 5787 0
The primary assessment question will be asked prior to each administration of Somatuline Autogel over the 4 year period
Secondary outcome [1] 241777 0
Efficacy of Somatuline Autogel measured by the completion of survey (eCRF) by treating physician.
Timepoint [1] 241777 0
Assessed prior to each administration of Somatuline Autogel over the 4 year period
Secondary outcome [2] 241778 0
Home Injection Training Requirements measured by the completion of survey (eCRF) by treating physician.
Timepoint [2] 241778 0
Assessed prior to each administration of Somatuline Autogel over the 4 year period
Secondary outcome [3] 241779 0
Acceptability of Home Injection measured by the completion of survey (eCRF) by treating physician.
Timepoint [3] 241779 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 Neuroendocrine tumours.
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] 1610 0
2430
Recruitment postcode(s) [2] 1611 0
2348
Recruitment postcode(s) [3] 1612 0
2310
Recruitment postcode(s) [4] 1613 0
2291
Recruitment postcode(s) [5] 1614 0
2077
Recruitment postcode(s) [6] 1615 0
2217
Recruitment postcode(s) [7] 1616 0
2065
Recruitment postcode(s) [8] 1617 0
5000
Recruitment postcode(s) [9] 1618 0
6008
Recruitment postcode(s) [10] 1619 0
6005

Funding & Sponsors
Funding source category [1] 4818 0
Commercial sector/Industry
Name [1] 4818 0
Ipsen Pty Ltd
Address [1] 4818 0
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, Victoria, Australia 3150.
Country [1] 4818 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] 4359 0
None
Name [1] 4359 0
Address [1] 4359 0
Country [1] 4359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6866 0
Hunter New England Human Reseach Ethics Committee
Ethics committee address [1] 6866 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 6866 0
Australia
Date submitted for ethics approval [1] 6866 0
28/03/2009
Approval date [1] 6866 0
27/04/2009
Ethics approval number [1] 6866 0

Summary
Brief summary
This study will compare the safety and tolerability of a treatment for neuroendocrine tumours 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 29515 0
Dr Tony Bonaventura
Address 29515 0
Department of Medical Oncology
Newcastle Private Hospital
14 Lookout Road (PO Box 466)
New Lambton Heights, NSW, 2305
Country 29515 0
Australia
Phone 29515 0
+61 2 4941 8424
Fax 29515 0
Email 29515 0
Tony.Bonaventura@mater.health.nsw.gov.au
Contact person for public queries
Name 12762 0
Mr Jay Dharma
Address 12762 0
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, Victoria, Australia, 3150
Country 12762 0
Australia
Phone 12762 0
+61 3 85448100
Fax 12762 0
+61 3 9562 5152
Email 12762 0
jay.dharma@ipsen.com
Contact person for scientific queries
Name 3690 0
Dr Dr Monica de Abadal
Address 3690 0
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, Victoria, Australia, 3150
Country 3690 0
Australia
Phone 3690 0
+61 3 85448100
Fax 3690 0
+61 3 9562 5152
Email 3690 0
monica.deabadal@ipsen.com

No information has been provided regarding IPD availability
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