A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis.

The aim of this 13-week, multicenter, randomized, double-blind, double-dummy, placebo- and positive-internal (celecoxib)-controlled, parallel-group study was to demonstrate the efficacy, safety, and tolerability of lumiracoxib in primary hip osteoarthritis (OA) patients. Eligible patients (n = 1,262; ACR criteria) were randomized (1:1:1) to receive lumiracoxib 100 mg once daily (o.d.) (n = 427), celecoxib 200 mg o.d. (n = 419), or matching placebo o.d. (n = 416) administered orally. The primary objective was to compare lumiracoxib 100 mg o.d. and placebo with respect to three co-primary efficacy variables: the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1 (WOMAC™ LK 3.1) questionnaire, the function subscale of the WOMAC™ LK 3.1 questionnaire, and patient's global assessment of disease activity (100-mm visual analog scale (VAS)) after 13 weeks of treatment. Of the 1,262 randomized patients, 951 completed the study. All randomized patients were included in the intention-to-treat and safety populations. Lumiracoxib was superior to the placebo (p < 0.001) after 13 weeks for all three co-primary endpoints. By week 13, the patient's global assessment of disease activity (100-mm VAS) improved by 23.3 mm (±SD, 27.83 mm) with lumiracoxib and 13.3 mm (±26.71 mm) with placebo. The WOMAC™ function score decreased by 10.4 (±13.56) with lumiracoxib and 6.8 (±12.55) with placebo. The WOMAC™ pain scores decreased by 3.4 (±4.16) with lumiracoxib and 2.2 (±3.94) with placebo at week 13. Similar results were observed for secondary endpoints: OA pain intensity and WOMAC™ total score. Lumiracoxib was similar to celecoxib for all three co-primary endpoints. All treatments were well tolerated. In conclusion, lumiracoxib is effective in reducing pain and improving function in hip OA patients.

Efficacy and safety of pantoprazole 20 mg once daily treatment in patients with ulcer-like functional dyspepsia.

OBJECTIVE: To investigate the efficacy of pantoprazole 20 mg once daily (o.d.) in relieving epigastric pain associated with ulcer-like functional dyspepsia. RESEARCH DESIGN AND METHODS: In this double-blind, placebo-controlled, multicentre study, patients experiencing ulcer-like functional dyspepsia, with epigastric pain as the predominant symptom, were randomised to receive pantoprazole 20 mg or placebo o.d. for 28 days. Primary endpoint was the complete relief (i.e. absence) from epigastric pain after 28 days' treatment. The odds ratio (OR) for pantoprazole/placebo and its 95% confidence intervals (CIs) were determined. Significant superiority of pantoprazole was concluded if the value 1.0 was above this interval. RESULTS: Of 419 patients (intention-to-treat [ITT]) randomised to treatment, 207 received pantoprazole and 212 received placebo. Epigastric pain relief was achieved after 28 days' treatment in 55% of pantoprazole recipients and 45% of placebo recipients (per-protocol [PP]: 58% and 47%, respectively). Pantoprazole demonstrated statistically significant superiority compared with placebo in the ITT (OR: 0.68; 95% CI: 0.46-0.99) and PP populations (OR: 0.64; 95% CI: 0.42-0.98). Pantoprazole was more efficacious than placebo in relieving heartburn and acid regurgitation after 7, 14 and 28 days of treatment. The sum score of gastrointestinal symptoms after 28 days was statistically significantly lower in the pantoprazole than placebo group. Fewer patients receiving concomitant psychotropic medication experienced relief from epigastric pain than those not receiving such medication. Adverse events did not significantly differ between pantoprazole and placebo. CONCLUSIONS: Results of this study suggest that pantoprazole 20 mg is more efficacious than placebo, and is a well-tolerated treatment for relieving epigastric pain in patients with ulcer-like functional dyspepsia. Further research is needed to confirm these findings.