Trial · NCT00141102
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | 6 month treatment duration | CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments. |
| Secondary | Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) | 6 month treatment duration | CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU. |
| Secondary | Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) | Month 6/Early Termination (ET) | Subjects rated response to question: "Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?" using a 1 to 5 grading scale where 1=very good and 5=very poor. |
| Secondary | Number of Subjects With SUs | 6 month treatment duration | Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU. |
| Secondary | Number of Subjects With CSULGIEs by History of GD Ulceration | 6 month treatment duration | CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments. |
| Secondary | Number of Subjects With Moderate to Severe Abdominal Symptoms | 6 month treatment duration | Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms". |
| Secondary | Number of Subjects Withdrawn Due to GI Adverse Events (AEs) | 6 month treatment duration | GI AEs were defined using MedDRA SOC "Gastrointestinal Disorders" but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions. |
| Secondary | Change From Baseline in Hemoglobin at Month 6/ET | Month 6/ET | |
| Secondary | Change From Baseline in Hematocrit at Month 6/ET | Month 6/ET | |
| Secondary | Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin | 6 month treatment duration | A clinically significant decrease from baseline was defined as a fall in hematocrit \> = 10 percentage points and/or hemoglobin \> = 2 g/dL. |
| Secondary | Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN) | 6 month treatment duration | GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males. |
| Secondary | Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET | Month 6/ET | |
| Secondary | Change From Baseline in Iron Binding Capacity to Month 6/ET | Month 6/ET | |
| Secondary | Change From Baseline in Ferretin to Month 6/ET | Month 6/ET | |
| Secondary | Change From Baseline in C-Reactive Protein to Month 6/ET | Month 6/ET | |
| Other | Number of Subjects Alive at the Post Trial Interview | 6 months following last dose | Interview occurred via telephone to obtain follow-up mortality and hospitalization information. |
| Other | Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview | 6 months following last dose | Interview occurred via telephone to obtain follow-up mortality and hospitalization information. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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