Study Evaluating PSI-697 in Patients With Scleritis

This study is not yet open for participant recruitment.

Verified by Wyeth, August 2006

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00367692

Purpose

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	Intervention	Phase
Scleritis	Drug: PSI-697	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Estimated Enrollment:	12
Study Start Date:	September 2006
Estimated Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367692

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3165A1-106
Study First Received:	August 21, 2006
Last Updated:	August 21, 2006
ClinicalTrials.gov Identifier:	NCT00367692
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Scleritis

Study placed in the following topic categories:

Scleritis
Eye Diseases

Additional relevant MeSH terms:

Scleral Diseases

ClinicalTrials.gov processed this record on January 16, 2009