NCT00367692

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

First QC Date

August 21, 2006

Last Update Submit

September 4, 2009

Conditions

Scleritis

Keywords

Scleritis

Outcome Measures

Primary Outcomes (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.

Interventions

PSI-697DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleritis

Interventions

2-(4-chlorobenzyl)-3-hydroxy-7,8,9,10-tetrahydrobenzo(H)quinoline-4-carboxylic acid

Condition Hierarchy (Ancestors)

Scleral DiseasesEye Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 23, 2006

Study Start

September 1, 2006

Study Completion

April 1, 2007

Last Updated

September 9, 2009

Record last verified: 2009-09