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NCT00068042 Clinical Trial

A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Acromegaly Clinical Trial

Official title:
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00068042
Other study ID # PEGA-0435-003
Secondary ID A6291004
Status Completed
Phase Phase 4
First received September 4, 2003
Last updated April 3, 2008
Start date April 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 the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.

Recruitment information / eligibility
Status Completed
Enrollment 100
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

- IGF-I levels >=1.3xULN (upper limit of normal) at screening

- No history of radiotherapy or prior treatment with other drugs for acromegaly

- Minimum of two months must have elapsed post surgery prior to screening

Exclusion Criteria:

- Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations

- AST/ALT >= 3xULN (upper limit 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

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

Locations
Country Name City State
Australia Pfizer Investigational Site Darlinghurst New South Wales
Australia Pfizer Investigational Site Fitzroy Victoria
Australia Pfizer Investigational Site Heidelberg Victoria
Australia Pfizer Investigational Site Westmead New South Wales
Brazil Pfizer Investigational Site Curitiba PR
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Rio de Janeiro RJ
Brazil Pfizer Investigational Site Sao Paulo SP
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Montreal Quebec
France Pfizer Investigational Site Le Kremlin Bicetre
France Pfizer Investigational Site Pessac
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Dresden
Germany Pfizer Investigational Site Essen
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Heidelberg
Germany Pfizer Investigational Site Marburg
Greece Pfizer Investigational Site Athens Attika/Greece
Greece Pfizer Investigational Site Piraeus
Ireland Pfizer Investigational Site Cork
Ireland Pfizer Investigational Site Dublin 9
Italy Pfizer Investigational Site Genova
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Torino
Norway Pfizer Investigational Site Oslo
Spain Pfizer Investigational Site Badalona Barcelona
Spain Pfizer Investigational Site Hospitalet de Llobregat Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Sevilla
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Linkoping
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Uppsala
United Kingdom Pfizer Investigational Site Belfast Ireland
United Kingdom Pfizer Investigational Site Leeds
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Ann Arbor Michigan
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 Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  France,  Germany,  Greece,  Ireland,  Italy,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
Secondary The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit
See also
  Status Clinical Trial Phase
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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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