A Prospective Safety Follow Up Study Of Subjects Enrolled... | NCT00471224

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

NCT00471224

Sponsor

Pfizer

Status

Completed

Last Update Posted

Feb 17, 2011Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Siderosis

Interventions

Observational Trial

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

May 7, 2007

First Submission Date that Met QC Criteria

May 7, 2007

First Posted Date

May 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2011

Last Update Posted Date

Feb 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients who have received drug.		Patients who have received drug.	Other: Observational Trial

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational Trial	Other	No intervention is being used in this study.	Patients who have received drug.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
follow up for ocular safety and clinical features of ocular siderosis		12 months

Secondary Outcomes

Measure	Description	Time Frame
ERG changes		12 months
Anterior segment and fundal photography		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Boston	Massachusetts	02114	United States
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D011009	Pneumoconiosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D008722	Methods
D008919	Investigative Techniques