Trial · NCT00141102
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
NCT00141102, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2010-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis. Trials, record NCT00141102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00141102
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
- NCT number
- NCT00141102
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 4,484 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid
- Interventions
- Celecoxib, Diclofenac + Omeprazole
- First posted
- 2005-09-01
- Last updated
- 2021-03-03
- Results first posted
- 2010-06-11
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | 6 month treatment duration | CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments. |
| Secondary | Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) | 6 month treatment duration | CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU. |
| Secondary | Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) | Month 6/Early Termination (ET) | Subjects rated response to question: "Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?" using a 1 to 5 grading scale where 1=very good and 5=very poor. |
| Secondary | Number of Subjects With SUs | 6 month treatment duration | Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU. |
| Secondary | Number of Subjects With CSULGIEs by History of GD Ulceration | 6 month treatment duration | CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments. |
| Secondary | Number of Subjects With Moderate to Severe Abdominal Symptoms | 6 month treatment duration | Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms". |
| Secondary | Number of Subjects Withdrawn Due to GI Adverse Events (AEs) | 6 month treatment duration | GI AEs were defined using MedDRA SOC "Gastrointestinal Disorders" but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions. |
| Secondary | Change From Baseline in Hemoglobin at Month 6/ET | Month 6/ET | |
| Secondary | Change From Baseline in Hematocrit at Month 6/ET | Month 6/ET | |
| Secondary | Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin | 6 month treatment duration | A clinically significant decrease from baseline was defined as a fall in hematocrit \> = 10 percentage points and/or hemoglobin \> = 2 g/dL. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | 6 month treatment duration | Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee. | participants | NUMBER |
| SECONDARY | Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) | 6 month treatment duration | ITT. n = number of subjects with CSULGIEs or SUs as confirmed by the committee. | participants | NUMBER |
| SECONDARY | Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) | Month 6/Early Termination (ET) | ITT. Number of Participants Analyzed = number of subjects with data available for the analysis. Last Observation Carried Forward (LOCF) method was used. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects With SUs | 6 month treatment duration | ITT. | participants | NUMBER |
| SECONDARY | Number of Subjects With CSULGIEs by History of GD Ulceration | 6 month treatment duration | ITT. n = number of subjects who had history or no history of GD ulceration. | participants | NUMBER |
| SECONDARY | Number of Subjects With Moderate to Severe Abdominal Symptoms | 6 month treatment duration | ITT | participants | NUMBER |
| SECONDARY | Number of Subjects Withdrawn Due to GI Adverse Events (AEs) | 6 month treatment duration | ITT | participants | NUMBER |
| SECONDARY | Change From Baseline in Hemoglobin at Month 6/ET | Month 6/ET | Safety population = all randomized subjects who received at least 1 dose of study medication. Number of Participants Analyzed = number of subjects with analyzable data. | grams (g)/deciliter (dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hematocrit at Month 6/ET | Month 6/ET | Safety population. Number of Participants Analyzed = number of subjects with analyzable data. | percent | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin | 6 month treatment duration | Safety population. Number of Participants Analyzed = number of subjects with analyzable data. | participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | Celecoxib | 20 | participants | ||
| Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | Oral Diclofenac Plus Omeprazole | 81 | participants | ||
| Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) | Celecoxib | 25 | participants | ||
| Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) | Oral Diclofenac Plus Omeprazole | 92 | participants | ||
| Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) | Celecoxib | 0.754 | Standard Error 0.020 | scores on a scale | |
| Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) | Oral Diclofenac Plus Omeprazole | 0.773 | Standard Error 0.019 | scores on a scale | |
| Number of Subjects With SUs | Celecoxib | 5 | participants | ||
| Number of Subjects With SUs | Oral Diclofenac Plus Omeprazole | 11 | participants | ||
| Number of Subjects With CSULGIEs by History of GD Ulceration | Celecoxib | History of GD Ulceration (n=395, 400) | 7 | participants | |
| Number of Subjects With CSULGIEs by History of GD Ulceration | Oral Diclofenac Plus Omeprazole | History of GD Ulceration (n=395, 400) | 13 | participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Celecoxib | 2,238 | |
| Overall Study | STARTED | Oral Diclofenac Plus Omeprazole | 2,246 | |
| Overall Study | Received Treatment | Celecoxib | 2,223 | |
| Overall Study | Received Treatment | Oral Diclofenac Plus Omeprazole | 2,237 | |
| Overall Study | COMPLETED | Celecoxib | 1,730 | |
| Overall Study | COMPLETED | Oral Diclofenac Plus Omeprazole | 1,621 | |
| Overall Study | NOT COMPLETED | Celecoxib | 508 | |
| Overall Study | NOT COMPLETED | Oral Diclofenac Plus Omeprazole | 625 |
Source ClinicalTrials.gov
Adverse events292
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 | Abdominal pain upper | Gastrointestinal disorders | Celecoxib | 96 | 2,223 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Oral Diclofenac Plus Omeprazole | 133 | 2,237 | |
| other | Diarrhoea | Gastrointestinal disorders | Celecoxib | 79 | 2,223 | |
| other | Diarrhoea | Gastrointestinal disorders | Oral Diclofenac Plus Omeprazole | 168 | 2,237 | |
| other | Dyspepsia | Gastrointestinal disorders | Celecoxib | 137 | 2,223 | |
| other | Dyspepsia | Gastrointestinal disorders | Oral Diclofenac Plus Omeprazole | 111 | 2,237 | |
| other | Gastritis | Gastrointestinal disorders | Celecoxib | 32 | 2,223 | |
| other | Gastritis | Gastrointestinal disorders | Oral Diclofenac Plus Omeprazole | 44 | 2,237 | |
| other | Nausea | Gastrointestinal disorders | Celecoxib | 33 | 2,223 | |
| other | Nausea | Gastrointestinal disorders | Oral Diclofenac Plus Omeprazole | 66 | 2,237 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Celecoxib | ||
| Total, all-cause mortality | Oral Diclofenac Plus Omeprazole | ||
| Total, other adverse events | Celecoxib | 530 | 2,223 |
| Total, other adverse events | Oral Diclofenac Plus Omeprazole | 669 | 2,237 |
| Total, serious adverse events | Celecoxib | 61 | 2,223 |
| Total, serious adverse events | Oral Diclofenac Plus Omeprazole | 61 | 2,237 |
Source ClinicalTrials.gov
Papers2
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | Trial comparisons |
| Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview | Trial comparisons |
| Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects With Moderate to Severe Abdominal Symptoms | Trial comparisons |
| Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects With SUs | Trial comparisons |
| Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) | Trial comparisons |
| Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects Withdrawn Due to GI Adverse Events (AEs) | Trial comparisons |
| Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects Alive at the Post Trial Interview | Trial comparisons |
| Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin | Trial comparisons |
| Celecoxib vs Oral Diclofenac Plus Omeprazole: 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/NCT00141102
GET https://conductscience.org/api/trials/v1/NCT00141102/results?page=2