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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

September 7, 2006
February 2, 2012
October 2006
November 2010   (final data collection date for primary outcome measure)
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.
The primary endpoint of this study is the incidence of clinically significant upper and/or lower GI events.
Complete list of historical versions of study NCT00373685 on ClinicalTrials.gov Archive Site
  • 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.
  • Outcomes Research secondary endpoints:
  • Patient satisfaction with celecoxib compared to nsNSAID therapy as measured by a Drug Satisfaction With Pain Medication Question as the primary measure of patient satisfaction
  • the Efficacy Subscale of the Satisfaction with Current Pain Medication Scale of the PTSS as the secondary measure of patient satisfaction, nsNSAID and celecoxib utilization, Non-study drug utilization,PPI and other gastro-protective drug utilization.
  • Safety secondary endpoints:
  • Incidence of:
  • Moderate to severe abdominal symptoms and withdrawal due to GI AEs,
  • Change in Hb and Hct from Baseline to Study Termination visit,
  • Incidence of fecal occult blood positivity at study termination.
Not Provided
Not Provided
 
GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
  • Drug: Celecoxib
    open-label
  • Drug: Any commercially available NSAID with the indication for osteoarthritis
    dosing as per USPI label related to the chosen commercially marketed NSAID
  • Experimental: Celecoxib
    dosing as per USPI label
    Intervention: Drug: Celecoxib
  • Active Comparator: NSAIDs
    Intervention: Drug: Any commercially available NSAID with the indication for osteoarthritis
Cryer B, Li C, Simon LS, Singh G, Stillman MJ, Berger MF. GI-REASONS: a novel 6-month, prospective, randomized, open-label, blinded endpoint (PROBE) trial. Am J Gastroenterol. 2013 Mar;108(3):392-400. doi: 10.1038/ajg.2012.467. Epub 2013 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8067
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00373685
A3191331
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

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