Objective To introduce the design of a non-inferiority clinical trial for evaluating the mild-to-moderate active ulcerative coli-tis. Methods Based on international literature and the European guide-line on the development of new medicinal products for the treatment of ul-cerative colitis, a clinical trial was designed in involving with the positive control, non-inferiority margin, primary endpoint and the dose-finding within accepted efficacy and safety for a treatment of mild-to-moderate active ulcerative colitis. A real example of ulcerative colitis was intro-duced and its primary data were simulated for quantitative analysis. Re-sult For the non-inferiority clinical trial on mild-to-moderate active ulcerative colitis, the standard positive control should be aminosalicylic acid (5-ASA) with the dose of 3 g/day, the non-inferior margin is approximately 15%, and the CAI scale is recommended as primary end-point. Conclusion This study can provide some important information for similar clinical research.

OBJECTIVE: Clinical presentation and physical signs may be unreliable in the diagnosis of stercoral colitis (SC). This study evaluates the value of computed tomography (CT) in distinguishing fatal from non-fatal SC. MATERIALS AND METHODS: Ten patients diagnosed as SC were obtained from inter-specialist conferences. Additional 13 patients with suspected SC were identified via the Radiology Information System (RIS). These patients were divided into two groups; fatal and non-fatal SCs. Their CT images are reviewed by two board-certified radiologists blinded to the clinical data and radiographic reports. RESULTS: SC occurred in older patients and displayed no gender predisposition. There was significant correlation between fatal SC and CT findings of dense mucosa (p = 0.017), perfusion defects (p = 0.026), ascites (p = 0.023), or abnormal gas (p = 0.033). The sensitivity, specificity, and accuracy of dense mucosa were 71%, 86%, and 81%, respectively. These figures were 75%, 79%, and 77% for perfusion defects; 75%, 80%, and 78% for ascites; and 50%, 93%, and 78% for abnormal gas, respectively. Each CT sign of mucosal sloughing and pericolonic abscess displayed high specificity of 100% and 93% for diagnosing fatal SC, respectively. However, this did not reach statistical significance in diagnosing fatal SC. CONCLUSION: CT appears to be valuable in discriminating fatal from non-fatal SC.
Adult ; Aged ; Aged, 80 and over ; Chi-Square Distribution ; Colitis/mortality/*radiography ; Contrast Media/diagnostic use ; Diagnosis, Differential ; Fecal Impaction/mortality/*radiography ; Female ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Risk Factors ; Sensitivity and Specificity ; Statistics, Nonparametric ; Tomography, X-Ray Computed/*methods