Trial · NCT00346216
Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
NCT00346216, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2017-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen. Trials, record NCT00346216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00346216
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
- NCT number
- NCT00346216
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 24,081 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Arthritis, Rheumatoid
- Interventions
- celecoxib, Ibuprofen, Naproxen
- First posted
- 2006-06-29
- Last updated
- 2021-03-03
- Other registries' IDs
- eudract:2004-002441-13
- Results first posted
- 2017-05-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). | Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months | APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology). |
| Secondary | The First Occurrence of a Major Adverse Cardiovascular Events (MACE) | ITT Population - 30 months; MITT Population - 42 months | MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA |
| Secondary | The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE) | ITT Population - 30 months; MITT Population - 42 months | CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer |
| Secondary | Change From Baseline in Patient's Assessment of Arthritis Pain (VAS) | ITT and MITT Population - Baseline to 42 months | VAS question "How much pain do you have" was graded on a scale from 0 to 100 with 0 indicating "No pain" and 100 indicating "Worst possible pain". |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). | Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months | ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit. | Percentage of Partcipants | NUMBER |
| SECONDARY | The First Occurrence of a Major Adverse Cardiovascular Events (MACE) | ITT Population - 30 months; MITT Population - 42 months | ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit. | Percentage of Participants | NUMBER |
| SECONDARY | The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE) | ITT Population - 30 months; MITT Population - 42 months | ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Patient's Assessment of Arthritis Pain (VAS) | ITT and MITT Population - Baseline to 42 months | ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit. | Number of participants | MEAN |
Source ClinicalTrials.gov
Results by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). | Celecoxib | ITT (N = 8072, 8040, 7969) | 2.3 | Percentage of Partcipants | |
| The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). | Ibuprofen | ITT (N = 8072, 8040, 7969) | 2.7 | Percentage of Partcipants | |
| The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). | Naproxen | ITT (N = 8072, 8040, 7969) | 2.5 | Percentage of Partcipants | |
| The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). | Celecoxib | MITT (N = 8030, 7990, 7933) | 1.7 | Percentage of Partcipants | |
| The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). | Ibuprofen | MITT (N = 8030, 7990, 7933) | 1.9 | Percentage of Partcipants | |
| The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). | Naproxen | MITT (N = 8030, 7990, 7933) | 1.8 | Percentage of Partcipants | |
| The First Occurrence of a Major Adverse Cardiovascular Events (MACE) | Celecoxib | ITT (N = 8072, 8040, 7969) | 4.2 | Percentage of Participants | |
| The First Occurrence of a Major Adverse Cardiovascular Events (MACE) | Ibuprofen | ITT (N = 8072, 8040, 7969) | 4.8 | Percentage of Participants | |
| The First Occurrence of a Major Adverse Cardiovascular Events (MACE) | Naproxen | ITT (N = 8072, 8040, 7969) | 4.3 | Percentage of Participants | |
| The First Occurrence of a Major Adverse Cardiovascular Events (MACE) | Celecoxib | MITT (N = 8030, 7990, 7933) | 3.1 | Percentage of Participants |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Celecoxib | 8,072 | |
| Overall Study | STARTED | Ibuprofen | 8,040 | |
| Overall Study | STARTED | Naproxen | 7,969 | |
| Overall Study | COMPLETED | Celecoxib | 5,664 | |
| Overall Study | COMPLETED | Ibuprofen | 5,580 | |
| Overall Study | COMPLETED | Naproxen | 5,621 | |
| Overall Study | NOT COMPLETED | Celecoxib | 2,408 | |
| Overall Study | NOT COMPLETED | Ibuprofen | 2,460 | |
| Overall Study | NOT COMPLETED | Naproxen | 2,348 |
Source ClinicalTrials.gov
Adverse events3,714
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 | Anaemia | Blood and lymphatic system disorders | Celecoxib | 207 | 8,030 | |
| other | Anaemia | Blood and lymphatic system disorders | Ibuprofen | 405 | 7,992 | |
| other | Anaemia | Blood and lymphatic system disorders | Naproxen | 310 | 7,933 | |
| other | Constipation | Gastrointestinal disorders | Celecoxib | 274 | 8,030 | |
| other | Constipation | Gastrointestinal disorders | Ibuprofen | 344 | 7,992 | |
| other | Constipation | Gastrointestinal disorders | Naproxen | 408 | 7,933 | |
| other | Diarrhoea | Gastrointestinal disorders | Celecoxib | 641 | 8,030 | |
| other | Diarrhoea | Gastrointestinal disorders | Ibuprofen | 538 | 7,992 | |
| other | Diarrhoea | Gastrointestinal disorders | Naproxen | 566 | 7,933 | |
| other | Dyspepsia | Gastrointestinal disorders | Celecoxib | 393 | 8,030 |
1 to 10 of 3,714Source ClinicalTrials.gov
See all 3,714 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Celecoxib | ||
| Total, all-cause mortality | Ibuprofen | ||
| Total, all-cause mortality | Naproxen | ||
| Total, other adverse events | Celecoxib | 4,268 | 8,030 |
| Total, other adverse events | Ibuprofen | 4,363 | 7,992 |
| Total, other adverse events | Naproxen | 4,337 | 7,933 |
| Total, serious adverse events | Celecoxib | 1,473 | 8,030 |
| Total, serious adverse events | Ibuprofen | 1,624 | 7,992 |
| Total, serious adverse events | Naproxen | 1,611 | 7,933 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT00346216
GET https://conductscience.org/api/trials/v1/NCT00346216/results?page=2