Trial · NCT00118365

Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

NCT00118365, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2015-01-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps. Trials, record NCT00118365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00118365

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Trial

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

Title: Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps
NCT number: NCT00118365
Status: Completed
Phases: Phase 3
Enrollment: 375 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Precancerous Condition
Interventions: placebo, eflornithine, sulindac, laboratory biomarker analysis
First posted: 2005-07-11
Last updated: 2015-01-22
Results first posted: 2015-01-22

Source ClinicalTrials.gov

Registered outcomes21

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

List	Outcome	Time frame	Description
Primary	Detection of Any Adenoma at the End of the Study	Up to 36 months	Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.
Secondary	Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment	Up to 36 months	This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.
Secondary	Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment	Up 36 months	The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort.
Secondary	Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment	Up 36 months	The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort. In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.
Secondary	Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment	Up to 36 months	PGE2 Responder = PGE2 values at 36-month are decreased by \>=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by \< 30% from baseline The analysis cohort is based on the participants whose data are available and complete.
Secondary	Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment	Up to 36 months	Putrescine responder = Putrescine values at 36-month are decreased by \>=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by \< 30% from baseline The analysis cohort is based on the participants whose data are available and complete.
Secondary	Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment	Up to 36 months	Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by \>=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by \< 30% from baseline The analysis cohort is based on the participants whose data are available and complete.
Secondary	Adverse Events With a Grade of 3 and Above	Up to 36 months	Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other. Per protocol, not all grade 3 events are considered as serious events.
Secondary	Baseline Putrescine by ODC Genotype	Baseline	ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
Secondary	Baseline Spermidine by ODC Genotype	Baseline	ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Detection of Any Adenoma at the End of the Study	Up to 36 months	This analysis is based on the participants who had the end-of-study colonscopy procedure done.	participants	NUMBER
SECONDARY	Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment	Up to 36 months	This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.	participants	NUMBER
SECONDARY	Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment	Up 36 months	In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.	participants	NUMBER
SECONDARY	Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment	Up 36 months	In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.	participants	NUMBER
SECONDARY	Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment	Up to 36 months	The analysis cohort is based on the participants whose data are available and complete.	participants	NUMBER
SECONDARY	Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment	Up to 36 months	The analysis cohort is based on the participants whose data are available and complete.	participants	NUMBER
SECONDARY	Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment	Up to 36 months	The analysis cohort is based on the participants whose data are available and complete.	participants	NUMBER
SECONDARY	Adverse Events With a Grade of 3 and Above	Up to 36 months		participants	NUMBER
SECONDARY	Baseline Putrescine by ODC Genotype	Baseline	The analysis cohort is based on the participants whose data are available and complete.	nmol/mg protein	MEDIAN
SECONDARY	Baseline Spermidine by ODC Genotype	Baseline	The analysis cohort is based on the participants whose data are available and complete.	nmol/mg protein	MEDIAN

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group130

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

Outcome	Group	Category	Value	Units
Detection of Any Adenoma at the End of the Study	Arm I (Eflornithine and Sulindac)	Yes	17	participants
Detection of Any Adenoma at the End of the Study	Arm II (Placebo)	Yes	53	participants
Detection of Any Adenoma at the End of the Study	Arm I (Eflornithine and Sulindac)	No	121	participants
Detection of Any Adenoma at the End of the Study	Arm II (Placebo)	No	76	participants
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment	Eflornithine and Sulindac + Low PGE2 at Baseline	Yes	12	participants
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment	Eflornithine and Sulindac + High PGE2 at Baseline	Yes	3	participants
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment	Placebo + Low PGE2 at Baseline	Yes	19	participants
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment	Placebo + High PGE2 at Baseline	Yes	21	participants
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment	Eflornithine and Sulindac + Low PGE2 at Baseline	No	41	participants
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment	Eflornithine and Sulindac + High PGE2 at Baseline	No	41	participants

1 to 10 of 130Source ClinicalTrials.gov

See all 130 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Eflornithine and Sulindac)	191
Overall Study	STARTED	Arm II (Placebo)	184
Overall Study	COMPLETED	Arm I (Eflornithine and Sulindac)	132
Overall Study	COMPLETED	Arm II (Placebo)	124
Overall Study	NOT COMPLETED	Arm I (Eflornithine and Sulindac)	59
Overall Study	NOT COMPLETED	Arm II (Placebo)	60

Source ClinicalTrials.gov

Adverse events2,774

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	Events
other	5 LBS X 2 WKS	Investigations	Arm I (Eflornithine and Sulindac)	0	191	0
other	5 LBS X 2 WKS	Investigations	Arm II (Placebo)	1	184	1
other	A-FIB	Cardiac disorders	Arm I (Eflornithine and Sulindac)	0	191	0
other	A-FIB	Cardiac disorders	Arm II (Placebo)	1	184	1
other	ABDOMINAL PAIN	Gastrointestinal disorders	Arm I (Eflornithine and Sulindac)	4	191	6
other	ABDOMINAL PAIN	Gastrointestinal disorders	Arm II (Placebo)	5	184	5
other	ABDOMINAL PAIN ABD CRAMPING AND BLOAT	Gastrointestinal disorders	Arm I (Eflornithine and Sulindac)	1	191	1
other	ABDOMINAL PAIN ABD CRAMPING AND BLOAT	Gastrointestinal disorders	Arm II (Placebo)	0	184	0
other	ABDOMINAL PAIN ABD. CRAMP AND CONSTIPATION	Gastrointestinal disorders	Arm I (Eflornithine and Sulindac)	1	191	2
other	ABDOMINAL PAIN ABD. CRAMP AND CONSTIPATION	Gastrointestinal disorders	Arm II (Placebo)	0	184	0

1 to 10 of 2,774Source ClinicalTrials.gov

See all 2,774 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Eflornithine and Sulindac)
Total, all-cause mortality	Arm II (Placebo)
Total, other adverse events	Arm I (Eflornithine and Sulindac)	173	191
Total, other adverse events	Arm II (Placebo)	154	184
Total, serious adverse events	Arm I (Eflornithine and Sulindac)	41	191
Total, serious adverse events	Arm II (Placebo)	28	184

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20538001	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
R01CA088078	Phase III Colon Cancer Prevention Trial	MEYSKENS, FRANK L.	UNIVERSITY OF CALIFORNIA-IRVINE	NATIONAL CANCER INSTITUTE	2002 to 2006

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Arm I (Eflornithine and Sulindac) vs Arm II (Placebo): Adverse Events With a Grade of 3 and Above	Trial comparisons
Arm I (Eflornithine and Sulindac) vs Arm II (Placebo): serious adverse events	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/NCT00118365

GET https://conductscience.org/api/trials/v1/NCT00118365/registered?page=2

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