Trial · NCT01298999

Trial of a Gastrin Receptor Antagonist in Barrett's Esophagus

NCT01298999, Phase 2, Completed, Columbia University; results first posted 2021-11-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of a Gastrin Receptor Antagonist in Barrett's Esophagus. Trials, record NCT01298999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01298999

On this page

Trial

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

Title: Trial of a Gastrin Receptor Antagonist in Barrett's Esophagus
NCT number: NCT01298999
Status: Completed
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: Columbia University
Conditions: Barrett's Esophagus
Interventions: YF476, Placebo
First posted: 2011-02-18
Last updated: 2021-11-23
Results first posted: 2021-11-23
Limitations and caveats: Relatively small sample size; study enrollment was limited to Barrett's esophagus without dysplasia, limited analysis of treatment related to later stages of disease progression; only one dose was tested which limits possibility that higher doses would have been more bioactive in Barrett's esophagus tissue.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Mean Ki67 Expression	Up to 3 months from baseline	The study is designed to examine change in tissue Ki67 expression, a marker of cellular proliferation.
Primary	Number of Participants That Experienced Change in Any Biomarker Expression	Up to 3 months from baseline	Participants with changes in gene expression were assessed by RNA-sequencing (i.e., sample has sufficient RNA for analysis) between baseline and up to 3 months are tallied.
Secondary	Number of Participants That Experienced Adverse Events	Up to 4 months from baseline	A measure of safety and tolerability. Participants with recorded adverse events were tallied. The events include any adverse events and/or severe adverse events.

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	Mean Ki67 Expression	Up to 3 months from baseline	Analysis limited to those who completed study (10 subjects in the intervention group and 10 subjects in the placebo group).	cells/mm2	MEAN
PRIMARY	Number of Participants That Experienced Change in Any Biomarker Expression	Up to 3 months from baseline	Analysis limited to those who completed study (10 subjects in the intervention group and 10 subjects in the placebo group).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants That Experienced Adverse Events	Up to 4 months from baseline		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Spread	Units
Mean Ki67 Expression	YF476		35.6	Standard Deviation 620.7	cells/mm2
Mean Ki67 Expression	Placebo		307.8	Standard Deviation 640.3	cells/mm2
Number of Participants That Experienced Change in Any Biomarker Expression	YF476		10		Participants
Number of Participants That Experienced Change in Any Biomarker Expression	Placebo		9		Participants
Number of Participants That Experienced Adverse Events	YF476	Serious Adverse Event	1		Participants
Number of Participants That Experienced Adverse Events	Placebo	Serious Adverse Event	0		Participants
Number of Participants That Experienced Adverse Events	YF476	Any Adverse Event	10		Participants
Number of Participants That Experienced Adverse Events	Placebo	Any Adverse Event	7		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	YF476	13
Overall Study	STARTED	Placebo	11
Overall Study	COMPLETED	YF476	10
Overall Study	COMPLETED	Placebo	10
Overall Study	NOT COMPLETED	YF476	3
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events44

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	Diarrhea	Gastrointestinal disorders	YF476	3	13
other	Diarrhea	Gastrointestinal disorders	Placebo	1	11
other	Abdominal pain	Gastrointestinal disorders	YF476	2	13
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	11
other	Constipation	Gastrointestinal disorders	YF476	2	13
other	Constipation	Gastrointestinal disorders	Placebo	1	11
other	Nausea	Gastrointestinal disorders	YF476	1	13
other	Nausea	Gastrointestinal disorders	Placebo	1	11
other	Rectal bleeding	Gastrointestinal disorders	YF476	1	13
other	Rectal bleeding	Gastrointestinal disorders	Placebo	1	11

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	YF476	0	13
Total, all-cause mortality	Placebo	0	11
Total, other adverse events	YF476	10	13
Total, other adverse events	Placebo	7	11
Total, serious adverse events	YF476	1	13
Total, serious adverse events	Placebo	0	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33782049	RESULT

Source 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 comparisons3

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

Comparison	Source
YF476 vs Placebo: Number of Participants That Experienced Change in Any Biomarker Expression	Trial comparisons
YF476 vs Placebo: deaths from any cause	Trial comparisons
YF476 vs 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/NCT01298999

GET https://conductscience.org/api/trials/v1/NCT01298999/events?page=2

API reference For AI assistants