- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00367692
Study Evaluating PSI-697 in Patients With Scleritis
September 4, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Exploratory, Double Blind, Placebo-controlled, Randomized, Single-dose, Cross-over, Proof of Mechanism Study of Orally Administered PSI-697 in Patients With Scleritis
To evaluate the safety of an orally administered single dose of PSI-697 in subjects with scleritis, as a model of inflammatory disease.
To evaluate by in vivo confocal microscopy (IVCM) the effect of a single dose of PSI-697 on leukocyte rolling in the scleral blood vessels of subjects with scleritis.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion: Age 18 or higher; A negative urine pregnancy test at screening for female subjects; Female subjects must be postmenopausal or surgically sterile.
Exclusion: Isolated episcleritis; Isolated posterior scleritis; Infectious scleritis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate by IVCM the effect of a single dose of PSI-697 on leukocyte rolling in scleral blood vessels of subjects with scleritis.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion
April 1, 2007
Study Registration Dates
First Submitted
August 21, 2006
First Submitted That Met QC Criteria
August 21, 2006
First Posted (Estimate)
August 23, 2006
Study Record Updates
Last Update Posted (Estimate)
September 9, 2009
Last Update Submitted That Met QC Criteria
September 4, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3165A1-106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Scleritis
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The Eye Center and The Eye Foundation for Research...CompletedScleritis and EpiscleritisSaudi Arabia
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Chung-Ang University Hosptial, Chung-Ang University...Ministry of Science, ICT and Future PlanningCompletedNecrotizing ScleritisKorea, Republic of
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John KempenCompletedNon-infectious, Non-necrotizing Anterior ScleritisUnited States
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Hospices Civils de LyonWithdrawnIdiopathic Refractory Scleritis
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National Eye Institute (NEI)Completed
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Metropolitan Eye Research & Surgery InstituteStanford University; Mallinckrodt; Ocular Imaging Research and Reading Center; Foresight...RecruitingScleritisUnited States
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National Eye Institute (NEI)Completed
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National Eye Institute (NEI)The Emmes Company, LLCCompleted
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Royal Surrey County Hospital NHS Foundation TrustUnknown
-
National Eye Institute (NEI)Terminated
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