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NCT00068029 Clinical Trial

Pegvisomant And Sandostatin LAR Combination Study

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00068029
Other study ID # PEGA-0435-005
Secondary ID A6291006
Status Completed
Phase Phase 4
First received September 4, 2003
Last updated April 3, 2008
Start date October 2003
Est. completion date May 2006

Study information
Verified date April 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pegvisomant/ Sandostatin LAR

• Sandostatin LAR

• Pegvisomant

Locations
Country Name City State
Australia Pfizer Investigational Site Darlinghurst New South Wales
Australia Pfizer Investigational Site Fitzroy Victoria
Australia Pfizer Investigational Site Fizroy Victoria
Brazil Pfizer Investigational Site Rio de Janeiro RJ
Brazil Pfizer Investigational Site São Paulo SP
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Toronto Ontario
France Pfizer Investigational Site Montpellier Cedex
France Pfizer Investigational Site Nice Cedex
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Dresden
Germany Pfizer Investigational Site Hannover
Italy Pfizer Investigational Site Genova
Italy Pfizer Investigational Site Messina
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Torino
Mexico Pfizer Investigational Site Col La Raza Mexico Df
Mexico Pfizer Investigational Site Mexico DF
Netherlands Pfizer Investigational Site Nijmegen
Norway Pfizer Investigational Site Oslo
Spain Pfizer Investigational Site Hospitalet de Llobregat Barcelona
Spain Pfizer Investigational Site Madrid
United Kingdom Pfizer Investigational Site Belfast Antrim
United Kingdom Pfizer Investigational Site Leeds
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Oxford
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Chapel Hill North Carolina
United States Pfizer Investigational Site Charlottesville Virginia
United States Pfizer Investigational Site Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  France,  Germany,  Italy,  Mexico,  Netherlands,  Norway,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
Secondary 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
See also
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Active, not recruiting NCT02092129 - Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly. N/A
Completed NCT02012127 - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
Active, not recruiting NCT01265121 - Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism. N/A
Terminated NCT00765323 - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly Phase 3
Completed NCT00531908 - Physiopathology of Sodium Retention in Acromegaly N/A
Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed NCT01278342 - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Phase 4
Active, not recruiting NCT01809808 - A Prospective Study of Outcome After Therapy for Acromegaly
Completed NCT00145405 - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Phase 4
Completed NCT00210457 - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Phase 3
Recruiting NCT05401084 - Diet in the Management of Acromegaly N/A
Recruiting NCT00005100 - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly N/A
Completed NCT00521300 - Preoperative Octreotide Treatment of Acromegaly Phase 4
Completed NCT03548415 - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Phase 2
Not yet recruiting NCT04066569 - Reproducibility and Utility of OGTT in Acromegaly N/A
Not yet recruiting NCT05298891 - Hypoproteic Diet in Acromegaly N/A
Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
Not yet recruiting NCT04529356 - The TMS Treatment for Postoperative Headache in GH Tumor N/A
Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3

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