Linding, the statistical analysis plan was amended from equivalence to non-inferiority. The power of the trial at this time was estimated to become around 86 plus a new non-inferiority bound was also added (ten mm compared together with the original eight mm initially specified for the original energy calculation).487 had been observed in all 3 therapy groups for Nocturnal Pain Intensity, BASDAI and each the Physicians’ and Patients’ Global Assessment of Disease Severity (Table 1), but there were no statistically substantial between-group differences in any parameter. Additional sufferers in the 400 mg celecoxib group met the ASAS 20 responder criteria at Weeks 2, 6 and 12 (58.three , 60.two and 60.2 , respectively) than within the 200 mg celecoxib (57.9 , 50.5 and 51.four , respectively) and diclofenac (54.8 , 54.eight and 57.four , respectively) remedy groups. There have been no statistically substantial between-group differences at Week 12 (Table 1). Treatment-emergent adverse events were reported for 176 patients. The incidence of adverse events was slightly higher for the diclofenac remedy group (56 ) than the 200 mg celecoxib (52 ) and 400 mg celecoxib (52 ) groups. The majority of adverse events had been mild-to-moderate in severity. Essentially the most typically occurring adverse events (!2 of sufferers in any therapy group) were dyspepsia and diarrhoea (Table two). Drug-related adverse events (as judged by the investigator) were observed in 43 of diclofenac-treated patients, 38 of 200 mg celecoxib-treated sufferers and 29 of 400 mg celecoxibtreated individuals. A total of 41 individuals experienced treatment-emergent adverse events that resulted in withdrawal of study medication (12 in the 200 mg celecoxib group, 14 inside the 400 mg celecoxib group, 15 in the diclofenac group). Extreme adverse events had been seasoned by five patients (1.5 ) through the trial: a single (0.9 ) patient in the 200 mg celecoxib group, two (1.9 ) within the 400 mg celecoxib group and two (1.7 ) within the diclofenac group. No severe adverse events within the celecoxib groups have been deemed by the investigator to be related to the study medication. Inside the diclofenac group, two patients experienced serious adverse eventsResultsThe majority of the 330 patients randomized and enrolled inside the study completed therapy (84/107 [78.5 ] 200 mg celecoxib, 88/ 108 [81.5 ] 400 mg celecoxib, 89/115 [77.4 ] diclofenac).1703768-74-4 uses Withdrawal rates because of lack of efficacy had been low in all remedy groups (seven of 107 [6.2349371-98-6 custom synthesis 5 ] 200 mg celecoxib, 3 of 108 [2.PMID:23903683 8 ] 400 mg celecoxib, eight of 115 [7.0 ] diclofenac; Figure 2). No statistically considerable between-group differences were observed in the incidence of withdrawal because of lack of efficacy. Most of the individuals were Caucasian (99.7 ) and male (72.four ), using a mean (SD) age of 43.eight (0.three) years. The mean time considering that diagnosis was ten.three (.eight) years, plus the majority of patients were constructive for HLA-B27 (92.1 ). Illness characteristics had been similar across therapy groups (data not shown). Global Discomfort Intensity decreased similarly in between baseline and Week 12 in all treatment groups (imply baseline values 66.three and 63.1 for 200 mg celecoxib and 400 mg celecoxib, respectively, and 67.0 for diclofenac; information not shown). Non-inferiority (based on non-inferiority margin of ten mm) of both celecoxib treatment groups versus diclofenac was demonstrated (Figure three). There have been no statistically significant betweengroup variations in Global Pain Intensity at Weeks 2 and 6 (information not shown). Improvements from baselin.