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

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

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Any commercially available NSAID with the indication for osteoarthritis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br>dosing as per USPI label | Drug: Celecoxib<br>* open-label<br>|
| Active Comparator: NSAIDs<br> | Drug: Any commercially available NSAID with the indication for osteoarthritis<br>* dosing as per USPI label related to the chosen commercially marketed NSAID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | 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. | Baseline through week 24 or Early Termination (ET) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Moderate to Severe Abdominal Symptoms | 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. | Baseline through week 24 or ET | 
| Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs) | 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 | Baseline through week 24 or ET | 
| Hemoglobin (Hb) at Baseline |  | Baseline | 
| Change From Baseline Hb at Week 24 |  | Baseline and Week 24 or ET | 
| Hematocrit (Hct) at Baseline |  | Baseline | 
| Change From Baseline Hct at Week 24 |  | Baseline and Week 24 or ET | 
| Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Clinically significant decrease in Hct (greater than or equal to 10 percent [≥10%]) and/or decrease in Hb (≥ 2 g/dL). | Baseline, Weeks 8, 16, 24 or ET | 
| Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | 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). | Baseline, Weeks 8, 16, 24 or ET | 
| Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | 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. | Baseline, Weeks 8, 16, 24 or ET | 
| Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | 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. | Baseline, Weeks 8, 16, 24 or ET | 
| Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | 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. | Baseline, Weeks 8, 16, 24 or ET | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GI events in patients with moderate GI risk treated with NSAIDS