AcromegalyPhase 4NCT00068029
Pegvisomant And Sandostatin LAR Combination Study
A Phase 4 study testing Pegvisomant/ Sandostatin LAR, Sandostatin LAR and Pegvisomant in people with Acromegaly, run by Pfizer at 33 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Pegvisomant/ Sandostatin LAR, Sandostatin LAR and Pegvisomant
- How many people
- 75 participants
- Where
- 33 sitesin 12 countries
- Study dates
- Oct 2003to May 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 12 countries.
33 sites in 12 countries
United Kingdom6 sites
Pfizer Investigational Site
Belfast, Antrim, BT12 6BA
Pfizer Investigational Site
Leeds, LS1 3EX
Pfizer Investigational Site
London, EC1A 7BE
Pfizer Investigational Site
London, SE1 7EH
Pfizer Investigational Site
Manchester, M20 4BX
Pfizer Investigational Site
Oxford, OX3 7LJ
United States4 sites
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7600
Pfizer Investigational Site
Charlottesville, Virginia, 22908
Pfizer Investigational Site
Los Angeles, California, 90048
Italy4 sites
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Messina, 98122
Pfizer Investigational Site
Milan, 20162
Pfizer Investigational Site
Torino
Australia3 sites
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010
Pfizer Investigational Site
Fitzroy, Victoria, 3165
Pfizer Investigational Site
Fizroy, Victoria, 3165
Canada3 sites
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Toronto, Ontario, M5G 1X5
Germany3 sites
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Hanover
Brazil2 sites
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 21941-590
Pfizer Investigational Site
São Paulo, São Paulo, 05403-060
France2 sites
Pfizer Investigational Site
Montpellier, 34295
Pfizer Investigational Site
Nice, 06202
Mexico2 sites
Pfizer Investigational Site
Col La Raza, Mexico DF, 02990
Pfizer Investigational Site
Mexico City, Mexico City, 06720
Spain2 sites
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08906
Pfizer Investigational Site
Madrid, Madrid, 28035
About this study
Official 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
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.
- Conditions
- Acromegaly
- Being tested
- Pegvisomant/ Sandostatin LAR, Sandostatin LAR, Pegvisomant
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegvisomant/ Sandostatin LARDrug
Sandostatin LARDrug
PegvisomantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2003 (estimated)
- Study startOct 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068029
- Sponsor's protocol ID
- PEGA-0435-005
- Other IDs
- A6291006
- Status last verified
- Apr 2008
- First submitted
- 4 Sep 2003
- Last updated
- 7 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00068029
- Acronym / sponsor ID
- PEGA-0435-005
- Conditions
- Acromegaly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- May 2006 (actual)
- First posted
- 5 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegvisomant/ Sandostatin LAR | Drug | – |
| Sandostatin LAR | Drug | – |
| Pegvisomant | Drug | – |
Primary outcome
Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
33 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegvisomant/ Sandostatin LAR, Sandostatin LAR and Pegvisomant in people with Acromegaly, run by Pfizer at 33 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United Kingdom, United States, Italy, Australia, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing treatment-emergent adverse events across the duration fo the study. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2008.