Trial · NCT00961350
A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
NCT00961350, Phase 3, Completed, POZEN; results first posted 2016-01-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers. Trials, record NCT00961350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00961350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
- NCT number
- NCT00961350
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 530 participants, actual
- Lead sponsor
- POZEN
- Conditions
- Gastric Ulcer
- Interventions
- PA32540, EC Aspirin 325
- First posted
- 2009-08-18
- Last updated
- 2016-02-18
- Results first posted
- 2016-01-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg | 6 months | The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached. |
| Secondary | The Number of Participants With Gastric and/or Duodenal Ulcers | 6 Months | The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment. |
| Secondary | The Number of Subjects With "Treatment Success" | 6 Months | Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation. |
| Secondary | The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events | 6 months | The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period |
| Secondary | The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit | 6 Months | Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were: * none: no symptoms * mild: awareness of symptom, but easily tolerated * moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep) * severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg | 6 months | Intent to Treat (ITT) Population | participants | NUMBER |
| SECONDARY | The Number of Participants With Gastric and/or Duodenal Ulcers | 6 Months | Intent to Treat (ITT) Population | participants | NUMBER |
| SECONDARY | The Number of Subjects With Treatment Success | 6 Months | Intent to Treat Population | participants | NUMBER |
| SECONDARY | The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events | 6 months | Intent to Treat (ITT) Population | participants | NUMBER |
| SECONDARY | The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit | 6 Months | Intent to Treat (ITT) Population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg | PA32540 | 10 | 1.8 to 6.8 | participants | |
| Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg | EC Aspirin | 23 | participants | ||
| The Number of Participants With Gastric and/or Duodenal Ulcers | PA32540 | 11 | participants | ||
| The Number of Participants With Gastric and/or Duodenal Ulcers | EC Aspirin | 31 | participants | ||
| The Number of Subjects With Treatment Success | PA32540 | 249 | participants | ||
| The Number of Subjects With Treatment Success | EC Aspirin | 220 | participants | ||
| The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events | PA32540 | 6 | participants | ||
| The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events | EC Aspirin | 22 | participants | ||
| The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit | PA32540 | 198 | participants | ||
| The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit | EC Aspirin | 135 | participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PA32540 | 265 | |
| Overall Study | STARTED | EC Aspirin | 265 | |
| Overall Study | Intent-to-Treat Population (ITT) | PA32540 | 265 | |
| Overall Study | Intent-to-Treat Population (ITT) | EC Aspirin | 265 | |
| Overall Study | Safety Population | PA32540 | 264 | |
| Overall Study | Safety Population | EC Aspirin | 265 | |
| Overall Study | COMPLETED | PA32540 | 218 | |
| Overall Study | COMPLETED | EC Aspirin | 198 | |
| Overall Study | NOT COMPLETED | PA32540 | 47 | |
| Overall Study | NOT COMPLETED | EC Aspirin | 67 |
Source ClinicalTrials.gov
Adverse events134
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 | Gastritis | Gastrointestinal disorders | PA32540 | 46 | 264 | 51 |
| other | Gastritis | Gastrointestinal disorders | EC Aspirin | 44 | 265 | 48 |
| other | Dyspepsia | Gastrointestinal disorders | PA32540 | 35 | 264 | 40 |
| other | Dyspepsia | Gastrointestinal disorders | EC Aspirin | 90 | 265 | 114 |
| other | Gastritis erosive | Gastrointestinal disorders | PA32540 | 27 | 264 | 29 |
| other | Gastritis erosive | Gastrointestinal disorders | EC Aspirin | 82 | 265 | 97 |
| other | Hiatus hernia | Gastrointestinal disorders | PA32540 | 27 | 264 | 27 |
| other | Hiatus hernia | Gastrointestinal disorders | EC Aspirin | 26 | 265 | 26 |
| other | Duodenitis | Gastrointestinal disorders | PA32540 | 15 | 264 | 17 |
| other | Duodenitis | Gastrointestinal disorders | EC Aspirin | 46 | 265 | 47 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PA32540 | ||
| Total, all-cause mortality | EC Aspirin | ||
| Total, other adverse events | PA32540 | 191 | 264 |
| Total, other adverse events | EC Aspirin | 224 | 265 |
| Total, serious adverse events | PA32540 | 16 | 264 |
| Total, serious adverse events | EC Aspirin | 24 | 265 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PA32540 vs EC Aspirin: The Number of Participants With Gastric and/or Duodenal Ulcers | Trial comparisons |
| PA32540 vs EC Aspirin: The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events | Trial comparisons |
| PA32540 vs EC Aspirin: The Number of Subjects With Treatment Success | Trial comparisons |
| PA32540 vs EC Aspirin: The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit | Trial comparisons |
| PA32540 vs EC Aspirin: Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg | Trial comparisons |
| PA32540 vs EC Aspirin: 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.
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/NCT00961350
GET https://conductscience.org/api/trials/v1/NCT00961350/events?page=2