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Completed

NCT Number: NCT00373685

GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)

This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

55 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Aguas Buenas, PR, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.

Exclusion criteria

  • GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.
  • Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.

Treatment and study plan

Celecoxib

Drug

open-label

Any commercially available NSAID with the indication for osteoarthritis

Drug

dosing as per USPI label related to the chosen commercially marketed NSAID

Primary outcomes

  1. Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)

    Time frame: Baseline through week 24 or Early Termination (ET)

    CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.

Secondary outcomes

  1. Percentage of Participants With Moderate to Severe Abdominal Symptoms

    Time frame: Baseline through week 24 or ET

    Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms"; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function.

  2. Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)

    Time frame: Baseline through week 24 or ET

    GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions

  3. Hemoglobin (Hb) at Baseline

    Time frame: Baseline

  4. Change From Baseline Hb at Week 24

    Time frame: Baseline and Week 24 or ET

  5. Hematocrit (Hct) at Baseline

    Time frame: Baseline

  6. Change From Baseline Hct at Week 24

    Time frame: Baseline and Week 24 or ET

  7. Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline

    Time frame: Baseline, Weeks 8, 16, 24 or ET

    Clinically significant decrease in Hct (greater than or equal to 10 percent [≥10%]) and/or decrease in Hb (≥ 2 g/dL).

  8. Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall

    Time frame: Baseline, Weeks 8, 16, 24 or ET

    Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).

  9. Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief

    Time frame: Baseline, Weeks 8, 16, 24 or ET

    Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

  10. Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief

    Time frame: Baseline, Weeks 8, 16, 24 or ET

    Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

  11. Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief

    Time frame: Baseline, Weeks 8, 16, 24 or ET

    Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

Other outcomes

  1. Percentage of Participants With Positive Blood Fecal Occult

    Time frame: Week 24 or ET

    Positive blood fecal occult; blood in feces that is not visibly apparent

  2. Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization

    Time frame: Baseline through week 24 or ET

    PPI and other gastric protective drug (defined as Histamine-2 receptor antagonists [H2RA], misoprostol, sucralfate, and others such as antacids) utilization.

  3. Percentage of Participants With Non-study Medication Utilization

    Time frame: Baseline through week 24 or ET

    Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Gastrointestinal (GI) Randomized Event And Safety Open-Label NSAID Study (GI-Reasons): A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) In Osteoarthritis Patients

Acronym: GI-REASONS

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 8, 2006
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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