A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00471224

Purpose

This protocol intends to detail investigations necessary to evaluate the ocular safety of subjects enrolled in study A4321001 and who have received formulated Drug Product (Lot 8716-098).

Condition	Intervention
Siderosis	Other: Observational Trial

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).

Further study details as provided by Pfizer:

Primary Outcome Measures:

follow up for ocular safety and clinical features of ocular siderosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

ERG changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Anterior segment and fundal photography [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	16
Study Start Date:	June 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients who have received drug. Patients who have received drug.	Other: Observational Trial No intervention is being used in this study.

Eligibility

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

A subset of subjects enrolled in study A4321001 and who have received formulated drug product.

Criteria

Inclusion Criteria:

A subset of subjects enrolled in study A4321001 and who have received formulated drug product (Lot 8716-098) will be included in the safety follow up study.

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471224

Locations

United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030

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:	A4321004
Study First Received:	May 7, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00471224
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lung Diseases, Interstitial
Respiratory Tract Diseases
Lung Diseases
Pneumoconiosis

Disorders of Environmental Origin
Siderosis
Occupational Diseases
Coal worker's pneumoconiosis

ClinicalTrials.gov processed this record on January 16, 2009