Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00068029




Registration number
NCT00068029
Ethics application status
Date submitted
4/09/2003
Date registered
5/09/2003
Date last updated
7/04/2008

Titles & IDs
Public title
Pegvisomant And Sandostatin LAR Combination Study
Scientific title
A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly
Secondary ID [1] 0 0
A6291006
Secondary ID [2] 0 0
PEGA-0435-005
Universal Trial Number (UTN)
Trial acronym
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
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pegvisomant/ Sandostatin LAR
Treatment: Drugs - Sandostatin LAR
Treatment: Drugs - Pegvisomant

Treatment: Drugs: Pegvisomant/ Sandostatin LAR


Treatment: Drugs: Sandostatin LAR


Treatment: Drugs: Pegvisomant
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Diagnosis of acromegaly

- Received previous radiation and/or surgical treatment for their GH (Growth Hormone)
producing pituitary adenoma and have required medical therapy due to failure to
normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment

- Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to
enrollment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or
IGF-I concentrations

- Patients on current medical therapy other than Sandostatin LAR

- AST/ALT >= 3xULN (upper limits of normal)

- Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI

- Visual field defects (except post-surgical stable residual defects)

- Unable to self administer drug

- Radiotherapy within 12 months of entering the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Fitzroy
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Fizroy
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3165 - Fitzroy
Recruitment postcode(s) [3] 0 0
3165 - Fizroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Virginia
Country [5] 0 0
Brazil
State/province [5] 0 0
RJ
Country [6] 0 0
Brazil
State/province [6] 0 0
SP
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
France
State/province [9] 0 0
Montpellier Cedex
Country [10] 0 0
France
State/province [10] 0 0
Nice Cedex
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Dresden
Country [13] 0 0
Germany
State/province [13] 0 0
Hannover
Country [14] 0 0
Italy
State/province [14] 0 0
Genova
Country [15] 0 0
Italy
State/province [15] 0 0
Messina
Country [16] 0 0
Italy
State/province [16] 0 0
Milano
Country [17] 0 0
Italy
State/province [17] 0 0
Torino
Country [18] 0 0
Mexico
State/province [18] 0 0
DF
Country [19] 0 0
Mexico
State/province [19] 0 0
Mexico Df
Country [20] 0 0
Netherlands
State/province [20] 0 0
Nijmegen
Country [21] 0 0
Norway
State/province [21] 0 0
Oslo
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Antrim
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Leeds
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Manchester
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the safety and tolerability of combination therapy
with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00068029
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/ct2/show/NCT00068029