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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00373685
First received: September 7, 2006
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Drug: Celecoxib
Drug: Any commercially available NSAID with the indication for osteoarthritis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) [ Time Frame: Baseline through week 24 or Early Termination (ET) ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Percentage of Participants With Moderate to Severe Abdominal Symptoms [ Time Frame: Baseline through week 24 or ET ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs) [ Time Frame: Baseline through week 24 or ET ] [ Designated as safety issue: Yes ]
    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

  • Hemoglobin (Hb) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change From Baseline Hb at Week 24 [ Time Frame: Baseline and Week 24 or ET ] [ Designated as safety issue: Yes ]
  • Hematocrit (Hct) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change From Baseline Hct at Week 24 [ Time Frame: Week 24 or ET ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ] [ Designated as safety issue: Yes ]
    Clinically significant decrease in Hct (greater than or equal to 10 percent [≥10%]) and/or decrease in Hb (≥ 2 g/dL).

  • Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ] [ Designated as safety issue: No ]
    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.


Enrollment: 8067
Study Start Date: October 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib
dosing as per USPI label
Drug: Celecoxib
open-label
Active Comparator: NSAIDs Drug: Any commercially available NSAID with the indication for osteoarthritis
dosing as per USPI label related to the chosen commercially marketed NSAID

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373685

  Show 777 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00373685     History of Changes
Other Study ID Numbers: A3191331
Study First Received: September 7, 2006
Results First Received: October 26, 2011
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
GI events in patients with moderate GI risk treated with NSAIDS

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014