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Completed

NCT Number: NCT00141102

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Genk, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib

Drug

Participants are assigned to one of two groups in parallel for the duration of the study

Diclofenac + Omeprazole

Drug

Participants are assigned to one of two groups in parallel for the duration of the study

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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".

  6. 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.

  7. Change From Baseline in Hemoglobin at Month 6/ET

    Time frame: Month 6/ET

  8. Change From Baseline in Hematocrit at Month 6/ET

    Time frame: Month 6/ET

  9. 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.

  10. 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.

  11. Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET

    Time frame: Month 6/ET

  12. Change From Baseline in Iron Binding Capacity to Month 6/ET

    Time frame: Month 6/ET

  13. Change From Baseline in Ferretin to Month 6/ET

    Time frame: Month 6/ET

  14. Change From Baseline in C-Reactive Protein to Month 6/ET

    Time frame: Month 6/ET

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

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

Acronym: CONDOR

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 1, 2005
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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