Trial Outcomes & Findings for Celebrex (Celecoxib) Treatment of Laryngeal Papilloma (NCT NCT00592319)

Results Overview

Criteria for the recurrence: the site scoring \>4, plus visible lesion found in \>50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

12-month follow up

Results posted on

2012-08-31

Participant Flow

3 years

Many patients, who were eligible for this study, finally declined to participate this study due to a safety concern with Celebrex

Participant milestones

Participant milestones
Measure	Control once-time routine surgery with (either of CO2 laser at continue model and 10.0-20.0 W, or "cold" surgery with micro-instruments), in 15 subjects	Experimental once-time PDL surgery at 6.0-8.0 W, followed by oral taking of Celecoxib (100mg,BID)for 9 months
Overall Study STARTED	2	8
Overall Study COMPLETED	2	5
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Control once-time routine surgery with (either of CO2 laser at continue model and 10.0-20.0 W, or "cold" surgery with micro-instruments), in 15 subjects	Experimental once-time PDL surgery at 6.0-8.0 W, followed by oral taking of Celecoxib (100mg,BID)for 9 months
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=2 Participants treated with routine surgery (CO2 laser or "cold" microsurgery), in 15 cases	Experimental n=8 Participants treated with once-time PDL, followed by oral taking of 9-month Celecoxib, in 15 cases	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12-month follow up

Population: The paticipants for analysis were those who had the recurrence or completed follow-up period. The analysis was per protocol, and follow-up period was 12 months.

Criteria for the recurrence: the site scoring \>4, plus visible lesion found in \>50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.

Outcome measures

Outcome measures
Measure	Control n=2 Participants treated with once-time routine surgery	Experiment n=5 Participants treated with both of once-time PDL and 9-month Celebrex
Number of Case With Papilloma Recurrence During a 12-month Follow up	2 case Interval 0.0 to 0.0	5 case Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 12 months

Population: 12-month follow-up

The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.

Outcome measures

Outcome measures
Measure	Control n=2 Participants treated with once-time routine surgery	Experiment n=5 Participants treated with both of once-time PDL and 9-month Celebrex
Time Course (Month) With Papilloma Recurrence During 12-month Follow up	3.5 month Interval 3.0 to 4.0	5.2 month Interval 2.0 to 10.0

Adverse Events

Experiment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Dr. Zhi Wang

Trustee of Boston Univ. Medical Campus

Phone: 617-414-1590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place