Trial · NCT00527787
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
NCT00527787, Phase 3, Completed, POZEN; results first posted 2010-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen. Trials, record NCT00527787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00527787
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
- NCT number
- NCT00527787
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 434 participants, actual
- Lead sponsor
- POZEN
- Conditions
- Gastric Ulcer
- Interventions
- PN400 (VIMOVO), Naproxen
- First posted
- 2007-09-11
- Last updated
- 2010-12-28
- Results first posted
- 2010-12-28
Source ClinicalTrials.gov
Registered outcomes9
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 | 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 Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers | 6 months | The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort |
| Secondary | The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer | 6 Months | The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period |
| Secondary | The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment | 6 months | The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period |
| Secondary | Heartburn Symptom Resolution, 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. |
| Secondary | Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire | change from baseline at 6 Months | Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: "since treatment started, has there been any change in your upper abdominal pain and/or discomfort?" Answers would be better/about the same/worse. Participants with the response "better" (instead of "about the same" or "worse"), are tabulated by treatment group. |
| Secondary | Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales | baseline to 6 Months | Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for "pain intensity" is: 2-47 |
| Secondary | Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales | baseline to 6 Months | Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35. |
| Secondary | Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales | baseline to 6 Months | Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) \& statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) \& question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23 |
Source ClinicalTrials.gov
Outcomes9
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 | 6 months | Intent to Treat (ITT) Population | Participants | NUMBER |
| SECONDARY | The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers | 6 months | Intent to Treat (ITT) Population | Participants | NUMBER |
| SECONDARY | The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer | 6 Months | Intention to Treat (ITT) Population | Participants | NUMBER |
| SECONDARY | The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment | 6 months | Intent to treat (ITT) population | Participants | NUMBER |
| SECONDARY | Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit | 6 months | Intent to Treat (ITT) Population | participants | NUMBER |
| SECONDARY | Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire | change from baseline at 6 Months | Intent to Treat (ITT) Population | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales | baseline to 6 Months | Intent to Treat (ITT) Population | Units on SODA Subscale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales | baseline to 6 Months | Intent to Treat (ITT) Population | Units on SODA Subscale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales | baseline to 6 Months | Intent to Treat (ITT) Population | Units on SODA Subscale | LEAST_SQUARES_MEAN |
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 | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Gastric Ulcer Confirmed by Endoscopy | PN400 (VIMOVO) | 9 | 1.9 to 7.7 | Participants | |
| Number of Participants With Gastric Ulcer Confirmed by Endoscopy | Naproxen | 50 | 17.7 to 29.4 | Participants | |
| The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers | PN400 (VIMOVO) | 114 | 45.4 to 59.1 | Participants | |
| The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers | Naproxen | 149 | 62.4 to 75.1 | Participants | |
| The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer | PN400 (VIMOVO) | 7 | 1.3 to 6.5 | Participants | |
| The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer | Naproxen | 26 | 8.0 to 17.1 | Participants | |
| The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment | PN400 (VIMOVO) | 1 | 0 to 2.5 | Participants | |
| The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment | Naproxen | 11 | 2.6 to 8.9 | Participants | |
| Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit | PN400 (VIMOVO) | 140 | participants | ||
| Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit | Naproxen | 65 | participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PN400 (VIMOVO) | 218 | |
| Overall Study | STARTED | Naproxen | 216 | |
| Overall Study | COMPLETED | PN400 (VIMOVO) | 180 | |
| Overall Study | COMPLETED | Naproxen | 153 | |
| Overall Study | NOT COMPLETED | PN400 (VIMOVO) | 38 | |
| Overall Study | NOT COMPLETED | Naproxen | 63 |
Source ClinicalTrials.gov
Adverse events72
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 erosive | Gastrointestinal disorders | PN400 (VIMOVO) | 45 | 218 | 45 |
| other | Gastritis erosive | Gastrointestinal disorders | Naproxen | 81 | 216 | 81 |
| other | Gastritis | Gastrointestinal disorders | PN400 (VIMOVO) | 39 | 218 | 39 |
| other | Gastritis | Gastrointestinal disorders | Naproxen | 28 | 216 | 28 |
| other | Dyspepsia | Gastrointestinal disorders | PN400 (VIMOVO) | 36 | 218 | 36 |
| other | Dyspepsia | Gastrointestinal disorders | Naproxen | 65 | 216 | 65 |
| other | Diarrhoea | Gastrointestinal disorders | PN400 (VIMOVO) | 14 | 218 | 14 |
| other | Diarrhoea | Gastrointestinal disorders | Naproxen | 13 | 216 | 13 |
| other | Abdominal distension | Gastrointestinal disorders | PN400 (VIMOVO) | 11 | 218 | 11 |
| other | Abdominal distension | Gastrointestinal disorders | Naproxen | 10 | 216 | 10 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PN400 (VIMOVO) | ||
| Total, all-cause mortality | Naproxen | ||
| Total, other adverse events | PN400 (VIMOVO) | 170 | 218 |
| Total, other adverse events | Naproxen | 176 | 216 |
| Total, serious adverse events | PN400 (VIMOVO) | 5 | 218 |
| Total, serious adverse events | Naproxen | 6 | 216 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PN400 (VIMOVO) vs Naproxen: The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer | Trial comparisons |
| PN400 (VIMOVO) vs Naproxen: The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers | Trial comparisons |
| PN400 (VIMOVO) vs Naproxen: Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit | Trial comparisons |
| PN400 (VIMOVO) vs Naproxen: The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment | Trial comparisons |
| PN400 (VIMOVO) vs Naproxen: Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire | Trial comparisons |
| PN400 (VIMOVO) vs Naproxen: Number of Participants With Gastric Ulcer Confirmed by Endoscopy | Trial comparisons |
| PN400 (VIMOVO) vs Naproxen: 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/NCT00527787
GET https://conductscience.org/api/trials/v1/NCT00527787/events?page=2