Objective: To assess the efficacy and safety of a new medical device (MD; a capsule whose main component is a cross-linked protein) in the prevention of uncomplicated cystitis recurrences. Methods: Adult women with acute cystitis symptoms and a ciprofloxacin-susceptible isolate in urine culture were included in a randomized, double-blind clinical trial. Patients were treated with ciprofloxacin 500 mg/day and 1 capsule/day or matched placebo for 5 days, 1 capsule/day or placebo for 15 additional days, and 2 additional cycles of 1 capsule/day or placebo for 15 days on months 1 and 2 after initial treatment. Results: No recurrence was observed after the first month of follow-up in the MD-treated group. In addition, symptomatic recurrence was reduced by 19.4% compared with placebo after 6 months. Conclusions: The new MD can help prevent the recurrence of uncomplicated cystitis as well as help to reduce antibiotic use in management of urinary tract infection in women.

Gelatine tannate has been recently licensed as a medical device for the treatment of acute diarrhoea. Gelatine tannate is thought to act locally on the gut wall by forming a protective protein-based film and allowing the precipitation of pro-inflammatory mucoproteins from the intestinal mucus responsible for local inflammation, and subsequently eliminated through the faeces. In order to assess safety and efficacy of gelatine tannate, one randomised, parallel, double-blinded and placebo-controlled study was conducted by general practitioners in 40 adult patients diagnosed with acute diarrhoea (test formulation: capsules containing 500 mg of gelatine tannate).Safety was evaluated by monitoring adverse events (frequency, intensity and relation of adverse events to the administered treatments), laboratory parameters and vital signs between the pre-and post-study visits (primary study endpoints). Efficacy was evaluated in terms of mean decrease of both the daily frequency of watery stools (Stool Decrease Index, SDI) and the severity of the abdominal pain assessed using a 100-mm visual analogue scale (Pain Decrease Index, PDI). Statistical analyses were performed according to the principles of intention-to-treat and perprotocol.

A xyloglucan-based nasal spray provided greater relief of rhinosinusitis symptoms than a physiological saline spray and was well tolerated. Trial registration number (EUDRACT): 2014-000143-32.

The study was conducted in order to assess the bioequivalence of two capsule formulations (test and reference) containing 20 mg of omeprazole (5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl) methyl]sulfinyl]-1H-benzimidazole, CAS 73590-58-6). Fifty healthy male and female volunteers were treated in a single-centre, randomised, repeated-dose (once daily for six consecutive days), open-label, two-way crossover study, with a washout period of at least 9 days between treatments. Plasma samples were collected up to 12 h post-dosing for the determination of omeprazole by HPLC with photodiode array detector (DAD). The evaluation of bioequivalence was based on the following pharmacokinetic parameters that were calculated by standard non-compartmental methods: area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUCt) and that extrapolated to infinity (AUC) and the maximumobserved concentration (Cmax). The 90% confidence interval around the ratios (test/reference) (obtained by analysis of variance, ANOVA) were 0.92-1.04 forCmax, 0.88-1.05 for AUCt, and 0.88-1.05 for AUC, i.e., within the predefined acceptable range for the conclusion of bioequivalence. The study indicated that the test and reference formulations containing 20 mg of omeprazole are bioequivalent in terms of both the rate and extent of bioavailability.

Omeprazole LSS performed poorly in estimating CL/F using 2 separate estimation approaches and does not seem to be a suitable method for determining CYP2C19 activity.