Trial · NCT00081263

Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia

NCT00081263, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2017-09-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia. Trials, record NCT00081263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00081263

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
NCT number: NCT00081263
Status: Completed
Phases: Phase 2
Enrollment: 130 participants, actual
Lead sponsor: Gynecologic Oncology Group
Conditions: Cervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3, Stage 0 Cervical Cancer
Interventions: Celecoxib, Laboratory Biomarker Analysis, Placebo
First posted: 2004-04-08
Last updated: 2017-09-15
Results first posted: 2017-09-15

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Histologic Regression	Post treatment evaluation was done 14 to 18 weeks after treatment randomization	Whether or not patients with CIN 2/3 or CIN 3 upon entry experience a complete remission (or partial regression to CIN 1) in the post-treatment excisional biopsy.
Primary	Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0	Assessed every cycle while on treatment, 30 days after the last cycle of treatment	Number of participants with a grade of 3 or higher during the treatment period.
Other	To Examine the Association of Histologic Response in COX-2 in Tissue	Up to 18 weeks
Other	To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment	Up to 18 weeks
Other	HPV Viral Load Before and After Treatment	Up to 18 weeks
Other	To Examine the Association of Histologic Response in the Levels of Celecoxib in Serum During Treatment.	Up to 18 weeks
Other	Levels of Serum bFGF	Up to 18 weeks
Other	Levels of Serum VEGF	Up to 18 weeks
Other	To Determine the Feasibility of Digital Imaging Using Pathologist's Diagnosis and Diagnostic Technique (Web-based or Standard Method).	Baseline
Other	To Examine the Association of Histologic Response in Proliferation Index (Ki67).	Up to 18 weeks

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Histologic Regression	Post treatment evaluation was done 14 to 18 weeks after treatment randomization	Eligible, Treated, and Evaluable patients	percentage of participants	NUMBER
PRIMARY	Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0	Assessed every cycle while on treatment, 30 days after the last cycle of treatment	Eligible and treated patients.	participants	NUMBER
OTHER_PRE_SPECIFIED	To Examine the Association of Histologic Response in COX-2 in Tissue	Up to 18 weeks
OTHER_PRE_SPECIFIED	To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment	Up to 18 weeks
OTHER_PRE_SPECIFIED	HPV Viral Load Before and After Treatment	Up to 18 weeks
OTHER_PRE_SPECIFIED	To Examine the Association of Histologic Response in the Levels of Celecoxib in Serum During Treatment.	Up to 18 weeks
OTHER_PRE_SPECIFIED	Levels of Serum bFGF	Up to 18 weeks
OTHER_PRE_SPECIFIED	Levels of Serum VEGF	Up to 18 weeks
OTHER_PRE_SPECIFIED	To Determine the Feasibility of Digital Imaging Using Pathologist's Diagnosis and Diagnostic Technique (Web-based or Standard Method).	Baseline
OTHER_PRE_SPECIFIED	To Examine the Association of Histologic Response in Proliferation Index (Ki67).	Up to 18 weeks

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Histologic Regression	Arm I (Celecoxib)		40	90% Confidence Interval 28 to 53	percentage of participants
Histologic Regression	Arm II (Placebo)		34.1	90% Confidence Interval 22 to 48	percentage of participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0	Arm I (Celecoxib)	Gastrointestinal	1		participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0	Arm II (Placebo)	Gastrointestinal	0		participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0	Arm I (Celecoxib)	Pain	0		participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0	Arm II (Placebo)	Pain	1		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Celecoxib)	67
Overall Study	STARTED	Arm II (Placebo)	63
Overall Study	COMPLETED	Arm I (Celecoxib)	50
Overall Study	COMPLETED	Arm II (Placebo)	41
Overall Study	NOT COMPLETED	Arm I (Celecoxib)	17
Overall Study	NOT COMPLETED	Arm II (Placebo)	22

Source ClinicalTrials.gov

Adverse events70

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hemoglobin	Blood and lymphatic system disorders	Arm I (Celecoxib)	1	67
other	Hemoglobin	Blood and lymphatic system disorders	Arm II (Placebo)	0	63
other	Constitutional Symptoms - Other	General disorders	Arm I (Celecoxib)	0	67
other	Constitutional Symptoms - Other	General disorders	Arm II (Placebo)	1	63
other	Sweating	General disorders	Arm I (Celecoxib)	0	67
other	Sweating	General disorders	Arm II (Placebo)	1	63
other	Weight Gain	General disorders	Arm I (Celecoxib)	1	67
other	Weight Gain	General disorders	Arm II (Placebo)	1	63
other	Fatigue	General disorders	Arm I (Celecoxib)	1	67
other	Fatigue	General disorders	Arm II (Placebo)	2	63

1 to 10 of 70Source ClinicalTrials.gov

See all 70 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Celecoxib)
Total, all-cause mortality	Arm II (Placebo)
Total, other adverse events	Arm I (Celecoxib)	25	67
Total, other adverse events	Arm II (Placebo)	25	63
Total, serious adverse events	Arm I (Celecoxib)	0	67
Total, serious adverse events	Arm II (Placebo)	1	63

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28285845	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA101165	GYNECOLOGIC ONCOLOGY GROUP	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	2003 to 2014

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Arm I (Celecoxib) vs Arm II (Placebo): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00081263

GET https://conductscience.org/api/trials/v1/NCT00081263/events?page=2

API reference For AI assistants