Trial · NCT01483144

Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

NCT01483144, Phase 3, Completed, Cancer Prevention Pharmaceuticals, Inc.; results first posted 2021-06-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP). Trials, record NCT01483144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01483144

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Trial

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

Title: Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)
NCT number: NCT01483144
Status: Completed
Phases: Phase 3
Enrollment: 171 participants, actual
Lead sponsor: Cancer Prevention Pharmaceuticals, Inc.
Conditions: Familial Adenomatous Polyposis
Interventions: Eflornithine, Eflornithine Placebo, Sulindac 150 MG, Sulindac placebo
First posted: 2011-12-01
Last updated: 2021-06-08
Results first posted: 2021-06-08

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Subjects With Any FAP-related Event.	Up to 48 months from the start of treatment	Progression of disease by evaluation of FAP-related events over the course of study treatment
Secondary	Improvement in Investigator Upper GI Assessment	through month 12 assessment	Global assessment of change in upper GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint.
Secondary	Improvement in Investigator Lower GI Assessment	through month 12 assessment	Global assessment of change in lower GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With Any FAP-related Event.	Up to 48 months from the start of treatment	Intent to treat population with 171 subjects. Intent to treat population with lower GI anatomy (ower GI population) to evaluate lower GI FAP related events with 158 subjects.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Improvement in Investigator Upper GI Assessment	through month 12 assessment		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Improvement in Investigator Lower GI Assessment	through month 12 assessment		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Category	Value	Units
Number of Subjects With Any FAP-related Event.	Eflornithine Plus Sulindac	Number with FAP-related events	18	Participants
Number of Subjects With Any FAP-related Event.	Eflornithine Plus Sulindac Placebo	Number with FAP-related events	23	Participants
Number of Subjects With Any FAP-related Event.	Sulindac Plus Eflornithine Placebo	Number with FAP-related events	22	Participants
Number of Subjects With Any FAP-related Event.	Eflornithine Plus Sulindac	Number with Lower GI FAP-related events	2	Participants
Number of Subjects With Any FAP-related Event.	Eflornithine Plus Sulindac Placebo	Number with Lower GI FAP-related events	10	Participants
Number of Subjects With Any FAP-related Event.	Sulindac Plus Eflornithine Placebo	Number with Lower GI FAP-related events	9	Participants
Improvement in Investigator Upper GI Assessment	Eflornithine Plus Sulindac	Improved	11	Participants
Improvement in Investigator Upper GI Assessment	Eflornithine Plus Sulindac Placebo	Improved	10	Participants
Improvement in Investigator Upper GI Assessment	Sulindac Plus Eflornithine Placebo	Improved	10	Participants
Improvement in Investigator Upper GI Assessment	Eflornithine Plus Sulindac	Not Improved	45	Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Eflornithine Plus Sulindac	56
Overall Study	STARTED	Eflornithine Plus Sulindac Placebo	57
Overall Study	STARTED	Sulindac Plus Eflornithine Placebo	58
Overall Study	COMPLETED	Eflornithine Plus Sulindac	41
Overall Study	COMPLETED	Eflornithine Plus Sulindac Placebo	44
Overall Study	COMPLETED	Sulindac Plus Eflornithine Placebo	43
Overall Study	NOT COMPLETED	Eflornithine Plus Sulindac	15
Overall Study	NOT COMPLETED	Eflornithine Plus Sulindac Placebo	13
Overall Study	NOT COMPLETED	Sulindac Plus Eflornithine Placebo	15

Source ClinicalTrials.gov

Adverse events276

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	iron deficiency anaemia	Blood and lymphatic system disorders	Eflornithine Plus Sulindac	0	56	0
other	iron deficiency anaemia	Blood and lymphatic system disorders	Eflornithine Plus Sulindac Placebo	0	56	0
other	iron deficiency anaemia	Blood and lymphatic system disorders	Sulindac Plus Eflornithine Placebo	3	57	3
other	ear pain	Ear and labyrinth disorders	Eflornithine Plus Sulindac	1	56	1
other	ear pain	Ear and labyrinth disorders	Eflornithine Plus Sulindac Placebo	2	56	2
other	ear pain	Ear and labyrinth disorders	Sulindac Plus Eflornithine Placebo	4	57	4
other	diarrhoea	Gastrointestinal disorders	Eflornithine Plus Sulindac	7	56	8
other	diarrhoea	Gastrointestinal disorders	Eflornithine Plus Sulindac Placebo	8	56	12
other	diarrhoea	Gastrointestinal disorders	Sulindac Plus Eflornithine Placebo	6	57	9
other	nausea	Gastrointestinal disorders	Eflornithine Plus Sulindac	12	56	18

1 to 10 of 276Source ClinicalTrials.gov

See all 276 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Eflornithine Plus Sulindac	0	56
Total, all-cause mortality	Eflornithine Plus Sulindac Placebo	0	56
Total, all-cause mortality	Sulindac Plus Eflornithine Placebo	0	57
Total, other adverse events	Eflornithine Plus Sulindac	52	56
Total, other adverse events	Eflornithine Plus Sulindac Placebo	49	56
Total, other adverse events	Sulindac Plus Eflornithine Placebo	50	57
Total, serious adverse events	Eflornithine Plus Sulindac	11	56
Total, serious adverse events	Eflornithine Plus Sulindac Placebo	14	56
Total, serious adverse events	Sulindac Plus Eflornithine Placebo	11	57

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27480131	BACKGROUND	PubMed
32905675	RESULT	PubMed
34261858	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons0

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

None in this release.

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/NCT01483144

GET https://conductscience.org/api/trials/v1/NCT01483144/events?page=2

API reference For AI assistants