SiderosisNCT00471224
A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product
An observational study of Siderosis, run by Pfizer at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Siderosis
- What is being tested?
- Observational Trial
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2007to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A subset of subjects enrolled in study A4321001 and who have received formulated drug product.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Houston, Texas, 77030
About this study
Official title: A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).
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).
- Conditions
- Siderosis
- Being tested
- Observational Trial
- Medical subject headings
- Siderosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational TrialOther
No intervention is being used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have received drug. | Patients who have received drug. Receives: Other: Observational Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
follow up for ocular safety and clinical features of ocular siderosis
Measured: 12 months
Secondary outcomes (2)
ERG changes
Measured: 12 months
Anterior segment and fundal photography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SiderosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471224
- Sponsor's protocol ID
- A4321004
- Status last verified
- Feb 2011
- First submitted
- 7 May 2007
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).
- ClinicalTrials.gov ID
- NCT00471224
- Acronym / sponsor ID
- A4321004
- Conditions
- Siderosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 9 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have received drug. | – | Other: Observational TrialPatients who have received drug. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A subset of subjects enrolled in study A4321001 and who have received formulated drug product.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational TrialNo intervention is being used in this study. | Other | Patients who have received drug. |
Primary outcome
follow up for ocular safety and clinical features of ocular siderosis
Time frame: 12 months
2 secondary outcomes
ERG changes
Time frame: 12 months
Anterior segment and fundal photography
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Siderosis, run by Pfizer at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follow up for ocular safety and clinical features of ocular siderosis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011.