Trial Outcomes & Findings for OraTest in Combination With Visual Examination and Visual Examination Alone (NCT NCT00537199)

Results Overview

Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone. Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

Following two (2) scheduled visits for visual examination, up to one month following first exam

Results posted on

2016-05-13

Participant Flow

Recruitment Period: 06/04/07 through 06/22/07. Single participant recruited at UT MD Anderson Cancer Center although multi-center study.

Only 1 patient enrolled prior to sponsor Zila Biotechnology terminating study. Study monitoring done by sponsor; no final data available on part of University of Texas (UT) MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	OraTest + Visual Exam Visual oral exam, followed by OraTest Rinse Staining Procedure
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	OraTest + Visual Exam Visual oral exam, followed by OraTest Rinse Staining Procedure
Overall Study Study Terminated	1

Baseline Characteristics

OraTest in Combination With Visual Examination and Visual Examination Alone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OraTest + Visual Exam n=1 Participants Visual oral exam, followed by OraTest Rinse Staining Procedure
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Following two (2) scheduled visits for visual examination, up to one month following first exam

Population: No analysis was performed. Study was terminated by sponsor.

Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone. Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye.

Outcome measures

Outcome data not reported

Adverse Events

OraTest + Visual Exam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Chambers, MS, DMD / Professor

UT MD Anderson Cancer Center

Phone: 713-792-6510

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place