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Trial · NCT00527787

Results by group18

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

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With Gastric Ulcer Confirmed by EndoscopyPN400 (VIMOVO)91.9 to 7.7Participants
Number of Participants With Gastric Ulcer Confirmed by EndoscopyNaproxen5017.7 to 29.4Participants
The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal UlcersPN400 (VIMOVO)11445.4 to 59.1Participants
The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal UlcersNaproxen14962.4 to 75.1Participants
The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal UlcerPN400 (VIMOVO)71.3 to 6.5Participants
The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal UlcerNaproxen268.0 to 17.1Participants
The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of TreatmentPN400 (VIMOVO)10 to 2.5Participants
The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of TreatmentNaproxen112.6 to 8.9Participants
Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the VisitPN400 (VIMOVO)140participants
Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the VisitNaproxen65participants
Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia QuestionnairePN400 (VIMOVO)93Participants
Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia QuestionnaireNaproxen52Participants
Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) SubscalesPN400 (VIMOVO)-6Standard Error 0.7Units on SODA Subscale
Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) SubscalesNaproxen0Standard Error 0.7Units on SODA Subscale
Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) SubscalesPN400 (VIMOVO)-2.2Standard Error 0.3Units on SODA Subscale
Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) SubscalesNaproxen-0.5Standard Error 0.3Units on SODA Subscale
Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) SubscalesPN400 (VIMOVO)3.4Standard Error 0.4Units on SODA Subscale
Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) SubscalesNaproxen0.9Standard Error 0.4Units on SODA Subscale

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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