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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00471224
First received: May 7, 2007
Last updated: February 16, 2011
Last verified: February 2011
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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).

Resource links provided by NLM:


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 ]

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
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: 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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00471224     History of Changes
Other Study ID Numbers: A4321004
Study First Received: May 7, 2007
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Siderosis
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases

ClinicalTrials.gov processed this record on August 18, 2014