Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000780055
Ethics application status
Approved
Date submitted
13/09/2010
Date registered
20/09/2010
Date last updated
3/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pioglitazone in the treatment of acromegaly
Scientific title
The effects on insulin-like growth factor 1 (IGF-1) and growth hormone levels using Pioglitazone in the treatment of active acromegaly
Secondary ID [1] 252708 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 4396 0
Condition category
Condition code
Metabolic and Endocrine 4641 4641 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pioglitazone - 1month run in period of 15mg (2 weeks) and 30mg (2 weeks)orally daily, then target dose of 45mg orally daily for further 3 months
Intervention code [1] 4129 0
Treatment: Drugs
Comparator / control treatment
N/A - This is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5512 0
change in Insulin-like growth factor 1 (IGF-1) - measured on a fasting blood test
Timepoint [1] 5512 0
after 3 months on maximal dose (45 mg) - outcome to be assessed immediatly after the 3 months
Secondary outcome [1] 9278 0
change in area under the curve of glucose suppressed growth hormone level
Timepoint [1] 9278 0
after 3 months on maximal dose (45 mg) - outcome to be assessed immediately after the 3 months

Eligibility
Key inclusion criteria
Active acromegaly - clinical features, elevated IGF-1 and/or non-suppressible growth hormone (>1mcg/L) after 75g oral glucose.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Initiation or discontinuation of octreotide in the last 6 months
Initiation or discontinuation of cabergoline in the last 3 months if treatment caused >20% change in serum IGF-1
Congestive heart failure (New York Heart Association (NYHA)Grade 2 or above)
Current thiozolidinedione use
Current malignancy
Clinical liver disease

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)
Referral from responsible endocrinologists. Eligible patients will be directly contacted and explained about the study verbally and in writing, followed by enrolment of those who are willing to participate by one of the investigators. No allocations - single-arm/ open-label design
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 1604 0
New Zealand
State/province [1] 1604 0

Funding & Sponsors
Funding source category [1] 4572 0
Charities/Societies/Foundations
Name [1] 4572 0
A+ Charitable Trust
Country [1] 4572 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland district health board
Address
Auckland City Hospital, 2 Park Road, Grafton, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 4125 0
None
Name [1] 4125 0
N/A
Address [1] 4125 0
N/A
Country [1] 4125 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243931 0
Northern Y Ethics Committee (New Zealand)
Ethics committee address [1] 243931 0
3rd floor, Bank of New Zaland building
354 Victoria St
PO Box 1031
Hamilton
Ethics committee country [1] 243931 0
New Zealand
Date submitted for ethics approval [1] 243931 0
01/01/2009
Approval date [1] 243931 0
01/06/2009
Ethics approval number [1] 243931 0
NTY/09/01/004

Summary
Brief summary
To study the effects of pioglitazone (3 months at maximum dose of 45mg) on disease activity of acromegaly, as measured by IGF-1 level.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29332 0
Address 29332 0
Country 29332 0
Phone 29332 0
Fax 29332 0
Email 29332 0
Contact person for public queries
Name 12579 0
Associate Professor Andrew Grey
Address 12579 0
Department of Endocrinology, Level 1, Building 4, Greenlane Clinical Centre, Greenlane West, Auckland
Country 12579 0
New Zealand
Phone 12579 0
+64 9 3074949 ext. 26860
Fax 12579 0
Email 12579 0
a.grey@auckland.ac.nz
Contact person for scientific queries
Name 3507 0
Associate Professor Andrew Grey
Address 3507 0
Department of Endocrinology, Level 1, Building 4, Greenlane Clinical Centre, Greenlane West, Auckland
Country 3507 0
New Zealand
Phone 3507 0
+64 9 3074949 ext. 26860
Fax 3507 0
Email 3507 0
a.grey@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.