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Trial record 1 of 1 for:    NCT00373685
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GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) (GI-REASONS)

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ClinicalTrials.gov Identifier: NCT00373685
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : November 30, 2011
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 7, 2006
First Posted Date  ICMJE September 8, 2006
Results First Submitted Date  ICMJE October 26, 2011
Results First Posted Date  ICMJE November 30, 2011
Last Update Posted Date July 1, 2019
Study Start Date  ICMJE October 2006
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
The primary endpoint of this study is the incidence of clinically significant upper and/or lower GI events.
Change History Complete list of historical versions of study NCT00373685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • 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.
  • 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
  • Hemoglobin (Hb) at Baseline [ Time Frame: Baseline ]
  • Change From Baseline Hb at Week 24 [ Time Frame: Baseline and Week 24 or ET ]
  • Hematocrit (Hct) at Baseline [ Time Frame: Baseline ]
  • Change From Baseline Hct at Week 24 [ Time Frame: Baseline and Week 24 or ET ]
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2019)
  • 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
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
Official Title  ICMJE 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
Brief Summary This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Celecoxib
    dosing as per USPI label
    Intervention: Drug: Celecoxib
  • Active Comparator: NSAIDs
    Intervention: Drug: Any commercially available NSAID with the indication for osteoarthritis
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2011)
8067
Original Enrollment  ICMJE
 (submitted: September 7, 2006)
8000
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00373685
Other Study ID Numbers  ICMJE A3191331
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019

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