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Study Evaluating PSI-697 in Patients With Scleritis

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ClinicalTrials.gov Identifier: NCT00367692
Recruitment Status : Terminated
First Posted : August 23, 2006
Last Update Posted : September 9, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Scleritis Drug: PSI-697 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: An Exploratory, Double Blind, Placebo-controlled, Randomized, Single-dose, Cross-over, Proof of Mechanism Study of Orally Administered PSI-697 in Patients With Scleritis
Study Start Date : September 2006
Estimated Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To evaluate by IVCM the effect of a single dose of PSI-697 on leukocyte rolling in scleral blood vessels of subjects with scleritis.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367692


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier: NCT00367692     History of Changes
Other Study ID Numbers: 3165A1-106
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: September 9, 2009
Last Verified: September 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Scleritis

Additional relevant MeSH terms:
Scleritis
Scleral Diseases
Eye Diseases