Study Evaluating PSI-697 in Patients With Scleritis

Scleritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00367692
• Other study ID #: 3165A1-106
• Status: Terminated
• Phase: Phase 1
• First received: August 21, 2006
• Last updated: September 4, 2009
• Start date: September 2006
• Est. completion date: April 2007

Study information

• Verified date: September 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Scleritis

Intervention

Drug:
• PSI-697

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate by IVCM the effect of a single dose of PSI-697 on leukocyte rolling in scleral blood vessels of subjects with scleritis.