Trial · NCT00995410

Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers

NCT00995410, Phase 3, Completed, POZEN; results first posted 2016-02-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers. Trials, record NCT00995410. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00995410

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Trial

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

Title: Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers
NCT number: NCT00995410
Status: Completed
Phases: Phase 3
Enrollment: 380 participants, actual
Lead sponsor: POZEN
Conditions: Aspirin-Associated Gastric Ulcers
Interventions: PA32540
First posted: 2009-10-15
Last updated: 2016-02-17
Results first posted: 2016-02-17

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Subjects Monitored for Long-term Safety of PA32540	12 months	Incidence of adverse events and monitoring vital signs and clinical laboratory values. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC).
Secondary	Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation	12 months	Most Frequent (≥ 1%) Treatment Emergent Adverse Events by System Organ Class leading to Discontinuation

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects Monitored for Long-term Safety of PA32540	12 months		participants	NUMBER
SECONDARY	Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation	12 months	Overall Safety Population. Events were collected by systematic assessment. One subject reported two adverse events leading to discontinuation from the study. SOC from vocabulary, MedDRA (12.1).	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Units
Number of Subjects Monitored for Long-term Safety of PA32540	PA32540 Tablet		379	participants
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation	PA32540 Tablet	Subjects with any AE Leading to Discontinuation	51	participants
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation	PA32540 Tablet	Gastrointestinal disorders	15	participants
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation	PA32540 Tablet	Neoplasms benign, malignant and unspecified	7	participants
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation	PA32540 Tablet	Cardiac Disorders	6	participants
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation	PA32540 Tablet	Investigations	6	participants

Source ClinicalTrials.gov

Participant flow4

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

Period	Milestone	Group	Participants
Overall Study	STARTED	PA32540 Tablet	380
Overall Study	Treated	PA32540 Tablet	379
Overall Study	COMPLETED	PA32540 Tablet	292
Overall Study	NOT COMPLETED	PA32540 Tablet	88

Source ClinicalTrials.gov

Adverse events69

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	Bronchitis	Infections and infestations	PA32540 Tablet	16	379	17
other	Upper respiratory tract infection	Infections and infestations	PA32540 Tablet	16	379	19
other	Nasopharyngitis	Infections and infestations	PA32540 Tablet	15	379	18
other	Sinusitis	Infections and infestations	PA32540 Tablet	14	379	15
other	Diarrhoea	Gastrointestinal disorders	PA32540 Tablet	20	379	24
other	Dyspepsia	Gastrointestinal disorders	PA32540 Tablet	16	379	16
other	Nausea	Gastrointestinal disorders	PA32540 Tablet	16	379	20
other	Constipation	Gastrointestinal disorders	PA32540 Tablet	11	379	11
other	Abdominal pain upper	Gastrointestinal disorders	PA32540 Tablet	9	379	9
other	Back pain	Musculoskeletal and connective tissue disorders	PA32540 Tablet	16	379	18

1 to 10 of 69Source ClinicalTrials.gov

See all 69 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PA32540 Tablet
Total, other adverse events	PA32540 Tablet	280	379
Total, serious adverse events	PA32540 Tablet	55	379

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26725920	DERIVED

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 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/NCT00995410

GET https://conductscience.org/api/trials/v1/NCT00995410/events?page=2

API reference For AI assistants