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Trial record 1 of 1 for:    NCT00141102
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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 : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE September 1, 2005
Results First Submitted Date  ICMJE May 11, 2010
Results First Posted Date  ICMJE June 11, 2010
Last Update Posted Date March 3, 2021
Study Start Date  ICMJE October 2005
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2010)
Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
The primary endpoint of this study is the incidence of clinically significant upper and/or lower GI events (CSULGIEs). For the purposes of this trial CSULGIEs are considered any event that in clinical practice would impact the subject in terms of inpatie
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2010)
  • Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) [ Time Frame: 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.
  • Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) [ Time Frame: 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.
  • Number of Subjects With SUs [ Time Frame: 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.
  • Number of Subjects With CSULGIEs by History of GD Ulceration [ Time Frame: 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.
  • Number of Subjects With Moderate to Severe Abdominal Symptoms [ Time Frame: 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".
  • Number of Subjects Withdrawn Due to GI Adverse Events (AEs) [ Time Frame: 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.
  • Change From Baseline in Hemoglobin at Month 6/ET [ Time Frame: Month 6/ET ]
  • Change From Baseline in Hematocrit at Month 6/ET [ Time Frame: Month 6/ET ]
  • Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin [ Time Frame: 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.
  • 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) [ Time Frame: 6 month treatment duration ]
    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.
  • Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET [ Time Frame: Month 6/ET ]
  • Change From Baseline in Iron Binding Capacity to Month 6/ET [ Time Frame: Month 6/ET ]
  • Change From Baseline in Ferretin to Month 6/ET [ Time Frame: Month 6/ET ]
  • Change From Baseline in C-Reactive Protein to Month 6/ET [ Time Frame: Month 6/ET ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • The secondary endpoints of this study are:
  • The incidence of CSULGIEs plus symptomatic ulcers (SUs)
  • The Patients Global Assessment of Arthritis
  • Change in Hb and Hct from Baseline to Visit 6
  • The incidence of subjects who have a clinically significant d
Current Other Pre-specified Outcome Measures
 (submitted: May 11, 2010)
  • Number of Subjects Alive at the Post Trial Interview [ Time Frame: 6 months following last dose ]
    Interview occurred via telephone to obtain follow-up mortality and hospitalization information.
  • Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview [ Time Frame: 6 months following last dose ]
    Interview occurred via telephone to obtain follow-up mortality and hospitalization information.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
Official Title  ICMJE Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events
Brief Summary To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: Celecoxib
    Participants are assigned to one of two groups in parallel for the duration of the study
  • Drug: Diclofenac + Omeprazole
    Participants are assigned to one of two groups in parallel for the duration of the study
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Active Comparator: B
    Intervention: Drug: Diclofenac + Omeprazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2010)
4484
Original Enrollment  ICMJE
 (submitted: August 31, 2005)
4400
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
  • Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria:

  • Active GD ulceration or GD ulceration within 90 days of the screening visit.
  • Concomitant use of low dose aspirin
  • Previous MI, stroke or significant vascular disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   China,   Colombia,   Costa Rica,   Croatia,   Czechia,   Ecuador,   Estonia,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   India,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   Panama,   Peru,   Portugal,   Russian Federation,   Serbia,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Ukraine,   United Kingdom
Removed Location Countries Czech Republic,   Former Serbia and Montenegro,   Ireland
 
Administrative Information
NCT Number  ICMJE NCT00141102
Other Study ID Numbers  ICMJE A3191084
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP