NCT00592319 · STUDY IN CONTEXT

Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

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.

→

secondary · POSTED

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

12-month follow-up

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-papilloma
nct id: NCT00592319
trial label: Celebrex (Celecoxib) Treatment of Laryngeal Papilloma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-papilloma
nct id
NCT00592319
outcome key
om-0001
source section id
NCT00592319-om-0001
source outcome index
1
endpoint
Number of Case With Papilloma Recurrence During a 12-month Follow up
endpoint definition
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.
time origin
12-month follow up
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-papilloma
nct id
NCT00592319
outcome key
om-0000
source section id
NCT00592319-om-0000
source outcome index
0
endpoint
Time Course (Month) With Papilloma Recurrence During 12-month Follow up
endpoint definition
The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.
time origin
12 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
12-month follow-up
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-papilloma
nct id
NCT00592319
outcome key
om-0000
arm key
OG000
arm label
Control
regimen
treated with once-time routine surgery
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00592319-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-papilloma
nct id
NCT00592319
outcome key
om-0000
arm key
OG001
arm label
Experiment
regimen
treated with both of once-time PDL and 9-month Celebrex
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00592319-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-papilloma
nct id
NCT00592319
outcome key
om-0001
arm key
OG000
arm label
Control
regimen
treated with once-time routine surgery (CO2 laser or "cold" microsurgery)
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00592319-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-papilloma
nct id
NCT00592319
outcome key
om-0001
arm key
OG001
arm label
Experienment
regimen
treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00592319-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-papilloma
nct id
NCT00592319
harm key
EG000
source section id
NCT00592319-ae
event group key
EG000
event group label
Experiment
serious affected
0
serious at risk
8
other affected
0
other at risk
8
frequency threshold
0
collection period
Primary: cardiovascular events for 12 months
event definition
Others: laser and surgery complications for 12 months
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-papilloma
nct id
NCT00592319
harm key
EG001
source section id
NCT00592319-ae
event group key
EG001
event group label
Control
serious affected
0
serious at risk
2
other affected
0
other at risk
2
frequency threshold
0
collection period
Primary: cardiovascular events for 12 months
event definition
Others: laser and surgery complications for 12 months
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice