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Trial record 2 of 9 for:    "Connective Tissue Disease" | "Diclofenac"

Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis (CONDOR)

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ClinicalTrials.gov Identifier: NCT00141102
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : June 11, 2010
Last Update Posted : April 21, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Osteoarthritis
Arthritis, Rheumatoid
Interventions Drug: Celecoxib
Drug: Diclofenac + Omeprazole
Enrollment 4484
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description 200 milligrams (mg) twice daily (BID) plus omeprazole placebo and diclofenac slow release (SR) placebo Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Period Title: Overall Study
Started 2238 2246
Received Treatment 2223 2237
Completed 1730 1621
Not Completed 508 625
Reason Not Completed
Adverse Event             233             305
Laboratory Abnormality             9             33
Lack of Efficacy             21             26
Lost to Follow-up             29             32
Other             87             76
Withdrawal by Subject             112             142
Randomized But Did Not Receive Treatment             15             9
Death             2             2
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole Total
Hide Arm/Group Description 200 mg BID plus omeprazole placebo and diclofenac SR placebo Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo. Total of all reporting groups
Overall Number of Baseline Participants 2238 2246 4484
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2238 participants 2246 participants 4484 participants
< 55 years 176 164 340
55 to 59 years 122 113 235
60 to 64 years 721 742 1463
65 to 69 years 623 618 1241
70 to 74 years 361 390 751
> = 75 years 235 219 454
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2238 participants 2246 participants 4484 participants
Female
1848
  82.6%
1822
  81.1%
3670
  81.8%
Male
390
  17.4%
424
  18.9%
814
  18.2%
1.Primary Outcome
Title Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
Hide Description 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.
Time Frame 6 month treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2238 2246
Measure Type: Number
Unit of Measure: participants
20 81
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Life Table Extension
Comments Stratified by history of GD ulceration and by region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.32
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)
Hide Description 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.
Time Frame 6 month treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. n = number of subjects with CSULGIEs or SUs as confirmed by the committee.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2238 2246
Measure Type: Number
Unit of Measure: participants
25 92
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Life Table Extension
Comments Stratified by history of GD ulceration and by region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.93
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Patient’s Global Arthritis Assessment at Month 6/Early Termination (ET)
Hide Description 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.
Time Frame Month 6/Early Termination (ET)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Number of Participants Analyzed = number of subjects with data available for the analysis. Last Observation Carried Forward (LOCF) method was used.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2207 2213
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
0.754  (0.020) 0.773  (0.019)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4146
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -0.019
Confidence Interval (2-Sided) 95%
-0.06 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.023
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Subjects With SUs
Hide Description 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.
Time Frame 6 month treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2238 2246
Measure Type: Number
Unit of Measure: participants
5 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1132
Comments [Not Specified]
Method Life Table Extension
Comments Stratified by history of GD ulceration and by region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.29
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Subjects With CSULGIEs by History of GD Ulceration
Hide Description 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.
Time Frame 6 month treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. n = number of subjects who had history or no history of GD ulceration.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2238 2246
Measure Type: Number
Unit of Measure: participants
History of GD Ulceration (n=395, 400) 7 13
No History of GD Ulceration (n=1843, 1846) 13 68
6.Secondary Outcome
Title Number of Subjects With Moderate to Severe Abdominal Symptoms
Hide Description 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".
Time Frame 6 month treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2238 2246
Measure Type: Number
Unit of Measure: participants
132 162
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0495
Comments [Not Specified]
Method Life Table Extension
Comments Stratified by history of GD ulceration and by region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Subjects Withdrawn Due to GI Adverse Events (AEs)
Hide Description 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.
Time Frame 6 month treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
Overall Number of Participants Analyzed 2238 2246
Measure Type: Number
Unit of Measure: participants
114 167
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Life Table Extension
Comments Stratified by history of GD ulceration and by region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.52
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Hemoglobin at Month 6/ET
Hide Description [Not Specified]
Time Frame Month 6/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population = all randomized subjects who received at least 1 dose of study medication. Number of Participants Analyzed = number of subjects with analyzable data.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2184 2167
Least Squares Mean (Standard Error)
Unit of Measure: grams (g)/deciliter (dL)
-0.017  (0.019) -0.423  (0.019)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.406
Confidence Interval (2-Sided) 95%
0.36 to 0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.022
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Hematocrit at Month 6/ET
Hide Description [Not Specified]
Time Frame Month 6/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of Participants Analyzed = number of subjects with analyzable data.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2184 2167
Least Squares Mean (Standard Error)
Unit of Measure: percent
-0.306  (0.059) -1.425  (0.059)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.118
Confidence Interval (2-Sided) 95%
0.98 to 1.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.069
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin
Hide Description A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.
Time Frame 6 month treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of Participants Analyzed = number of subjects with analyzable data.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2184 2167
Measure Type: Number
Unit of Measure: participants
45 123
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by history of GD ulceration and by region.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 2.748
Confidence Interval (2-Sided) 95%
1.96 to 3.84
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)
Hide Description GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.
Time Frame 6 month treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = number of subjects with analyzable data.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
Overall Number of Participants Analyzed 2223 2237
Measure Type: Number
Unit of Measure: participants
GGT 26 86
AST 8 12
ALT 13 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments GGT
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 3.329
Confidence Interval (2-Sided) 95%
2.156 to 5.141
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments AST
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3809
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.509
Confidence Interval (2-Sided) 95%
0.618 to 3.684
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments ALT
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0264
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 2.089
Confidence Interval (2-Sided) 95%
1.081 to 4.038
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET
Hide Description [Not Specified]
Time Frame Month 6/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = number of subjects with analyzable data.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2223 2237
Least Squares Mean (Standard Error)
Unit of Measure: IU/L
GGT -2.689  (0.591) 7.455  (0.592)
AST -0.901  (0.239) 1.490  (0.239)
ALT -1.151  (0.364) 5.213  (0.364)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments GGT
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.144
Confidence Interval (2-Sided) 95%
-11.51 to -8.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.697
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments AST
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.391
Confidence Interval (2-Sided) 95%
-2.94 to -1.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.281
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments ALT
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.364
Confidence Interval (2-Sided) 95%
-7.20 to -5.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.428
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Iron Binding Capacity to Month 6/ET
Hide Description [Not Specified]
Time Frame Month 6/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = number of subjects with analyzable data.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
Overall Number of Participants Analyzed 2185 2171
Least Squares Mean (Standard Error)
Unit of Measure: microgram (ug)/dL
2.517  (1.158) 1.952  (1.161)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6795
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.565
Confidence Interval (2-Sided) 95%
-2.11 to 3.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.366
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Ferretin to Month 6/ET
Hide Description [Not Specified]
Time Frame Month 6/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = number of subjects with analyzable data.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2185 2170
Least Squares Mean (Standard Error)
Unit of Measure: ug/dL
-3.396  (2.224) -1.990  (2.228)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5920
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.406
Confidence Interval (2-Sided) 95%
-6.55 to 3.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.624
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in C-Reactive Protein to Month 6/ET
Hide Description [Not Specified]
Time Frame Month 6/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = number of subjects with analyzable data.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2185 2171
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
0.058  (0.032) 0.073  (0.032)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Oral Diclofenac Plus Omeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6819
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of region and history of GD ulceration with Baseline covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.015
Confidence Interval (2-Sided) 95%
-0.09 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.038
Estimation Comments [Not Specified]
16.Other Pre-specified Outcome
Title Number of Subjects Alive at the Post Trial Interview
Hide Description Interview occurred via telephone to obtain follow-up mortality and hospitalization information.
Time Frame 6 months following last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = number of subjects with follow-up information available.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2047 2048
Measure Type: Number
Unit of Measure: participants
2018 2023
17.Other Pre-specified Outcome
Title Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview
Hide Description Interview occurred via telephone to obtain follow-up mortality and hospitalization information.
Time Frame 6 months following last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = number of subjects with follow-up information available.
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description:
200 mg BID plus omeprazole placebo and diclofenac SR placebo
Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
Overall Number of Participants Analyzed 2047 2048
Measure Type: Number
Unit of Measure: participants
82 79
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Celecoxib Oral Diclofenac Plus Omeprazole
Hide Arm/Group Description 200 mg BID plus omeprazole placebo and diclofenac SR placebo Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
All-Cause Mortality
Celecoxib Oral Diclofenac Plus Omeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib Oral Diclofenac Plus Omeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   61/2223 (2.74%)   61/2237 (2.73%) 
Blood and lymphatic system disorders     
Normochromic normocytic anaemia  1  0/2223 (0.00%)  1/2237 (0.04%) 
Cardiac disorders     
Acute myocardial infarction  1  2/2223 (0.09%)  2/2237 (0.09%) 
Angina unstable  1  1/2223 (0.04%)  0/2237 (0.00%) 
Cardiogenic shock  1  1/2223 (0.04%)  0/2237 (0.00%) 
Coronary artery stenosis  1  1/2223 (0.04%)  1/2237 (0.04%) 
Myocardial infarction  1  1/2223 (0.04%)  0/2237 (0.00%) 
Myocardial ischaemia  1  0/2223 (0.00%)  1/2237 (0.04%) 
Ear and labyrinth disorders     
Hypoacusis  1  1/2223 (0.04%)  0/2237 (0.00%) 
Eye disorders     
Glaucoma  1  0/2223 (0.00%)  1/2237 (0.04%) 
Gastrointestinal disorders     
Abdominal pain  1  1/2223 (0.04%)  1/2237 (0.04%) 
Abdominal pain lower  1  0/2223 (0.00%)  1/2237 (0.04%) 
Abdominal pain upper  1  0/2223 (0.00%)  1/2237 (0.04%) 
Colitis  1  1/2223 (0.04%)  1/2237 (0.04%) 
Constipation  1  0/2223 (0.00%)  2/2237 (0.09%) 
Diarrhoea  1  0/2223 (0.00%)  2/2237 (0.09%) 
Duodenal ulcer  1  2/2223 (0.09%)  0/2237 (0.00%) 
Dyspepsia  1  0/2223 (0.00%)  1/2237 (0.04%) 
Enteritis  1  1/2223 (0.04%)  0/2237 (0.00%) 
Erosive oesophagitis  1  1/2223 (0.04%)  0/2237 (0.00%) 
Gastric ulcer  1  2/2223 (0.09%)  2/2237 (0.09%) 
Gastric ulcer haemorrhage  1  0/2223 (0.00%)  1/2237 (0.04%) 
Gastritis  1  0/2223 (0.00%)  1/2237 (0.04%) 
Gastritis erosive  1  0/2223 (0.00%)  1/2237 (0.04%) 
Gastrointestinal haemorrhage  1  1/2223 (0.04%)  0/2237 (0.00%) 
Inguinal hernia  1  0/2223 (0.00%)  1/2237 (0.04%) 
Nausea  1  1/2223 (0.04%)  3/2237 (0.13%) 
Reflux oesophagitis  1  1/2223 (0.04%)  0/2237 (0.00%) 
Umbilical hernia  1  0/2223 (0.00%)  1/2237 (0.04%) 
Vomiting  1  0/2223 (0.00%)  2/2237 (0.09%) 
General disorders     
Chest pain  1  1/2223 (0.04%)  0/2237 (0.00%) 
Death  1  0/2223 (0.00%)  1/2237 (0.04%) 
Disease progression  1  1/2223 (0.04%)  0/2237 (0.00%) 
Pyrexia  1  3/2223 (0.13%)  1/2237 (0.04%) 
Hepatobiliary disorders     
Cholangitis  1  0/2223 (0.00%)  1/2237 (0.04%) 
Cholecystitis acute  1  1/2223 (0.04%)  0/2237 (0.00%) 
Cholelithiasis  1  2/2223 (0.09%)  2/2237 (0.09%) 
Infections and infestations     
Acute sinusitis  1  1/2223 (0.04%)  0/2237 (0.00%) 
Appendicitis  1  1/2223 (0.04%)  0/2237 (0.00%) 
Arthritis bacterial  1  0/2223 (0.00%)  2/2237 (0.09%) 
Bronchopneumonia  1  0/2223 (0.00%)  2/2237 (0.09%) 
Burn infection  1  1/2223 (0.04%)  0/2237 (0.00%) 
Cellulitis  1  2/2223 (0.09%)  1/2237 (0.04%) 
Chronic sinusitis  1  0/2223 (0.00%)  1/2237 (0.04%) 
Device related infection  1  1/2223 (0.04%)  0/2237 (0.00%) 
Enterocolitis infectious  1  0/2223 (0.00%)  1/2237 (0.04%) 
Erysipelas  1  1/2223 (0.04%)  0/2237 (0.00%) 
Groin abscess  1  0/2223 (0.00%)  1/2237 (0.04%) 
Osteomyelitis  1  0/2223 (0.00%)  1/2237 (0.04%) 
Pulmonary tuberculosis  1  1/2223 (0.04%)  0/2237 (0.00%) 
Pyothorax  1  1/2223 (0.04%)  0/2237 (0.00%) 
Urinary tract infection  1  1/2223 (0.04%)  2/2237 (0.09%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/2223 (0.00%)  2/2237 (0.09%) 
Comminuted fracture  1  0/2223 (0.00%)  1/2237 (0.04%) 
Concussion  1  1/2223 (0.04%)  0/2237 (0.00%) 
Eye burns  1  1/2223 (0.04%)  0/2237 (0.00%) 
Fall  1  1/2223 (0.04%)  0/2237 (0.00%) 
Femur fracture  1  1/2223 (0.04%)  0/2237 (0.00%) 
Forearm fracture  1  0/2223 (0.00%)  2/2237 (0.09%) 
Gun shot wound  1  0/2223 (0.00%)  1/2237 (0.04%) 
Injury  1  1/2223 (0.04%)  1/2237 (0.04%) 
Joint sprain  1  0/2223 (0.00%)  1/2237 (0.04%) 
Lumbar vertebral fracture  1  1/2223 (0.04%)  0/2237 (0.00%) 
Medical device complication  1  0/2223 (0.00%)  1/2237 (0.04%) 
Meniscus lesion  1  1/2223 (0.04%)  1/2237 (0.04%) 
Muscle strain  1  1/2223 (0.04%)  0/2237 (0.00%) 
Radius fracture  1  0/2223 (0.00%)  1/2237 (0.04%) 
Rib fracture  1  1/2223 (0.04%)  0/2237 (0.00%) 
Road traffic accident  1  1/2223 (0.04%)  2/2237 (0.09%) 
Spinal compression fracture  1  1/2223 (0.04%)  0/2237 (0.00%) 
Thoracic vertebral fracture  1  0/2223 (0.00%)  1/2237 (0.04%) 
Tibia fracture  1  0/2223 (0.00%)  1/2237 (0.04%) 
Traumatic brain injury  1  0/2223 (0.00%)  1/2237 (0.04%) 
Upper limb fracture  1  1/2223 (0.04%)  0/2237 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  0/2223 (0.00%)  1/2237 (0.04%) 
Hyperuricaemia  1  0/2223 (0.00%)  1/2237 (0.04%) 
Hypoglycaemia  1  0/2223 (0.00%)  1/2237 (0.04%) 
Hypokalaemia  1  1/2223 (0.04%)  1/2237 (0.04%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/2223 (0.04%)  1/2237 (0.04%) 
Bone pain  1  0/2223 (0.00%)  1/2237 (0.04%) 
Chondropathy  1  1/2223 (0.04%)  0/2237 (0.00%) 
Intervertebral disc protrusion  1  1/2223 (0.04%)  1/2237 (0.04%) 
Muscular weakness  1  0/2223 (0.00%)  1/2237 (0.04%) 
Myalgia  1  0/2223 (0.00%)  1/2237 (0.04%) 
Osteoarthritis  1  4/2223 (0.18%)  4/2237 (0.18%) 
Rheumatoid arthritis  1  0/2223 (0.00%)  1/2237 (0.04%) 
Rotator cuff syndrome  1  0/2223 (0.00%)  1/2237 (0.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  0/2223 (0.00%)  1/2237 (0.04%) 
Basal cell carcinoma  1  0/2223 (0.00%)  1/2237 (0.04%) 
Brain neoplasm  1  1/2223 (0.04%)  0/2237 (0.00%) 
Breast cancer  1  0/2223 (0.00%)  1/2237 (0.04%) 
Colon cancer  1  1/2223 (0.04%)  0/2237 (0.00%) 
Endometrial cancer  1  0/2223 (0.00%)  1/2237 (0.04%) 
Gastric adenoma  1  0/2223 (0.00%)  1/2237 (0.04%) 
Hepatic neoplasm malignant  1  0/2223 (0.00%)  1/2237 (0.04%) 
Leukaemia  1  1/2223 (0.04%)  0/2237 (0.00%) 
Non-Hodgkin’s lymphoma  1  1/2223 (0.04%)  0/2237 (0.00%) 
Thyroid cancer  1  1/2223 (0.04%)  0/2237 (0.00%) 
Nervous system disorders     
Balance disorder  1  1/2223 (0.04%)  0/2237 (0.00%) 
Carotid artery stenosis  1  0/2223 (0.00%)  1/2237 (0.04%) 
Cerebral haemorrhage  1  1/2223 (0.04%)  0/2237 (0.00%) 
Cerebrovascular accident  1  1/2223 (0.04%)  2/2237 (0.09%) 
Dizziness  1  0/2223 (0.00%)  2/2237 (0.09%) 
Dysarthria  1  1/2223 (0.04%)  0/2237 (0.00%) 
Facial palsy  1  1/2223 (0.04%)  0/2237 (0.00%) 
Headache  1  1/2223 (0.04%)  1/2237 (0.04%) 
Hypoaesthesia  1  1/2223 (0.04%)  1/2237 (0.04%) 
Ischaemic stroke  1  0/2223 (0.00%)  2/2237 (0.09%) 
Sciatica  1  1/2223 (0.04%)  0/2237 (0.00%) 
Transient ischaemic attack  1  2/2223 (0.09%)  0/2237 (0.00%) 
Psychiatric disorders     
Major depression  1  1/2223 (0.04%)  0/2237 (0.00%) 
Suicide attempt  1  1/2223 (0.04%)  0/2237 (0.00%) 
Renal and urinary disorders     
Calculus urinary  1  0/2223 (0.00%)  1/2237 (0.04%) 
Haematuria  1  0/2223 (0.00%)  1/2237 (0.04%) 
Renal failure  1  0/2223 (0.00%)  1/2237 (0.04%) 
Renal failure acute  1  0/2223 (0.00%)  1/2237 (0.04%) 
Tubulointerstitial nephritis  1  0/2223 (0.00%)  1/2237 (0.04%) 
Reproductive system and breast disorders     
Ovarian cyst  1  0/2223 (0.00%)  1/2237 (0.04%) 
Ovarian cyst ruptured  1  1/2223 (0.04%)  0/2237 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/2223 (0.04%)  0/2237 (0.00%) 
Acute respiratory failure  1  1/2223 (0.04%)  0/2237 (0.00%) 
Bronchitis chronic  1  0/2223 (0.00%)  1/2237 (0.04%) 
Dyspnoea exertional  1  0/2223 (0.00%)  1/2237 (0.04%) 
Interstitial lung disease  1  0/2223 (0.00%)  1/2237 (0.04%) 
Nasal congestion  1  0/2223 (0.00%)  1/2237 (0.04%) 
Pneumothorax  1  0/2223 (0.00%)  1/2237 (0.04%) 
Pulmonary embolism  1  2/2223 (0.09%)  0/2237 (0.00%) 
Skin and subcutaneous tissue disorders     
Hypoaesthesia facial  1  1/2223 (0.04%)  0/2237 (0.00%) 
Surgical and medical procedures     
Carpal tunnel decompression  1  1/2223 (0.04%)  0/2237 (0.00%) 
Hip arthroplasty  1  1/2223 (0.04%)  0/2237 (0.00%) 
Open reduction of fracture  1  1/2223 (0.04%)  0/2237 (0.00%) 
Prolapse repair  1  1/2223 (0.04%)  0/2237 (0.00%) 
Rectocele repair  1  0/2223 (0.00%)  1/2237 (0.04%) 
Vascular disorders     
Deep vein thrombosis  1  1/2223 (0.04%)  0/2237 (0.00%) 
Embolism  1  1/2223 (0.04%)  0/2237 (0.00%) 
Hypertension  1  0/2223 (0.00%)  1/2237 (0.04%) 
Thrombophlebitis superficial  1  1/2223 (0.04%)  0/2237 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Celecoxib Oral Diclofenac Plus Omeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   530/2223 (23.84%)   669/2237 (29.91%) 
Gastrointestinal disorders     
Abdominal pain upper  1  96/2223 (4.32%)  133/2237 (5.95%) 
Diarrhoea  1  79/2223 (3.55%)  168/2237 (7.51%) 
Dyspepsia  1  137/2223 (6.16%)  111/2237 (4.96%) 
Gastritis  1  32/2223 (1.44%)  44/2237 (1.97%) 
Nausea  1  33/2223 (1.48%)  66/2237 (2.95%) 
General disorders     
Oedema peripheral  1  46/2223 (2.07%)  67/2237 (3.00%) 
Infections and infestations     
Nasopharyngitis  1  55/2223 (2.47%)  46/2237 (2.06%) 
Investigations     
Haemoglobin decreased  1  27/2223 (1.21%)  72/2237 (3.22%) 
Nervous system disorders     
Headache  1  66/2223 (2.97%)  48/2237 (2.15%) 
Vascular disorders     
Hypertension  1  76/2223 (3.42%)  84/2237 (3.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00141102     History of Changes
Other Study ID Numbers: A3191084
First Submitted: August 29, 2005
First Posted: September 1, 2005
Results First Submitted: May 11, 2010
Results First Posted: June 11, 2010
Last Update Posted: April 21, 2011