Pegvisomant And Sandostatin LAR Combination Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acromegaly	Drug: Pegvisomant/ Sandostatin LAR Drug: Sandostatin LAR Drug: Pegvisomant	Phase 4


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

Resource links provided by NLM:

Drug Information available for: Octreotide acetate Octreotide Pegvisomant

Genetic and Rare Diseases Information Center resources: Acromegaly

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of subjects experiencing treatment-emergent adverse events across the duration fo the study

Secondary Outcome Measures:

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


Estimated Enrollment:	75
Study Start Date:	October 2003
Study Completion Date:	May 2006

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068029

Show 33 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided


ClinicalTrials.gov Identifier:	NCT00068029 History of Changes
Other Study ID Numbers:	PEGA-0435-005, A6291006
Study First Received:	September 4, 2003
Last Updated:	April 3, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases	Nervous System Diseases Pituitary Diseases Octreotide Antineoplastic Agents Antineoplastic Agents, Hormonal Gastrointestinal Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015