Long Term Use of Pegvisomant For A Regulatory Post Marketing Commitment Plan - Full Text View

Purpose

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition	Intervention	Phase
Acromegaly	Drug: Pegvisomant	Phase IV

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Special Investigation Of Somavert (Pegvisomant) - Long Term Use - (Regulatory Post Marketing Commitment Plan).

Further study details as provided by Pfizer:

Primary Outcome Measures:

Factors considered to affect the safety and/or efficacy of this drug [ Time Frame: 5 years ] [ Designated as safety issue: No ]
The incidence of adverse drug reactions in this surveillance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

This surveillance is a non-interventional/observational surveillance and dose not have any secondary outcomes measures. [ Time Frame: There is no secondary outcomes for this surveillance. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Pegvisomant Patients taking Pegvisomant.	Drug: Pegvisomant Pegvisomant 10, 15 or 20mg powder and solvent for solution for injection. Dosage, Frequency : According to Japanese LPD. Duration : According to the protocol of A6291023, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 5 years after the first administration.

Detailed Description:

All the patients whom an investigator prescribes the first Pegvisomant should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The patients whom an investigator involving A6291023 prescribes the Pegvisomant.

Criteria

Inclusion Criteria:

Patients need to be administered Pegvisomant in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Pegvisomant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658879

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6291023
First Received:	April 9, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00658879
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Bone Diseases, Endocrine

Hypothalamic Diseases

Pituitary Diseases

Musculoskeletal Diseases

Endocrine System Diseases

Central Nervous System Diseases

Endocrinopathy

Brain Diseases

Bone Diseases

Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism

Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00658879