This double-blind, parallel, controlled and randomized trial compares the clinical efficacy and tolerance of a new NSAID (pro-drug of piroxicam), droxicam, at the dose of 20 mg/day against that of piroxicam at the same dose. The comparison is drawn after the administration to 30 patients with spinal osteoarthritis during 8 weeks after a single-blind placebo-period run-in of 7 days. Results show that both drugs improve, with statistical significance, all parameters evaluated (pain intensity, morning stiffness, nocturnal pain, pain after getting up and after 30 min standing, difficulty in daily living, frequency of pain exacerbations and the ability to do several daily activities). No statistically significant differences were found between groups. Only one case in the droxicam group and two in the piroxicam group reported subjective complaints of mild intensity that did not require additional treatment or interruption of the study.

The influence of an antacid on droxicam pharmacokinetics was investigated in 12 healthy male volunteers. A two way cross-over study was performed after the oral administration of 20 mg of droxicam (Ombolan capsules) and droxicam together with an antacid (Mucal powder). The plasma concentrations of piroxicam, the active moiety of droxicam, were determined by a high-performance liquid chromatographic method. The pharmacokinetic parameter values (mean +/- RSD) of piroxicam after administration of droxicam alone were: AUC0-->infinity = 125.5 +/- 25.1 micrograms.h/l, Cmax = 2.08 +/- 19.9 micrograms/l, tmax = 7.08 +/- 36.8 h and t1/2 = 46.3 +/- 27.0 h. Following administration of droxicam together with the antacid the values obtained for the same parameters were: AUC0-->infinity = 135.1 +/- 24.1 micrograms.h/l. Cmax = 1.85 +/- 23.9 micrograms/l, tmax = 8.17 +/- 34.9 h and t1/2 = 52.0 +/- 22.4 h. These results indicate that concurrent administration of the antacid does not significantly change the bioavailability and pharmacokinetics of droxicam.

This double-blind randomized controlled trial compares the efficacy of droxicam (20mg/day) and that of indomethacin (100mg/day) administered to 20 patients (7 men, 13 women; aged 54.7 +/- 13.2 years) with active classical or definite rheumatoid arthritis during 9 weeks, after a 7-day single-blind run-in paracetamol (1,500mg/day) period. Evaluations were carried out at weeks 0 (washout), 1,2,4,6 and 9. After 9 weeks of treatment, both drugs showed a statistically significant improvement of joint pain intensity, articular index (number of swollen or painful joints and degree of involvement), duration of morning stiffness, functional capacity, and level of fatigue. Inter-treatment differences at all study intervals were not observed. Grip strength improved only in indomethacin-treated patients. Withdrawals due to lack of therapeutic efficacy did not occur. Side effects occurred in four patients from each group. One patient in the indomethacin group withdrew at the week 1 due to epigastric pain and heartburn. In conclusion, droxicam (20mg/day) seems to be as effective as indomethacin (100mg/day) in the alleviation of symptoms in patients with rheumatoid arthritis.

This randomized, controlled and double-blind clinical trial compares the efficacy of droxicam (20mg/day) with that of indomethacin (75mg/day) in 40 RA patients (11 male, 29 female) aged (+/- SD) 53 +/- 12.5 years. After a 7-day single-blind run-in placebo period, patients were divided into two groups and treated for 9 weeks. Assessments were done at baseline and at the end of the 1st, 2nd, 4th, 6th and 9th weeks. Both drugs improved significantly the articular pain, the duration of morning stiffness, the articular index, the functional status and the degree of fatigue. Patient's and doctor's opinions were in accordance with the above-mentioned results. The effect of both drugs was more noticeable in the first 2 weeks of treatment. Droxicam was found to be statistically more active than indomethacin in alleviating morning stiffness and improving the functional status. The improvement of the variables induced by droxicam increased progressively throughout the study whereas that induced by indomethacin remained unchanged after the 2nd or 4th week of treatment. One patient treated with indomethacin withdrew from the study due to staggering and dizziness and several patients reported dyspepsia. Droxicam seems to be as effective as indomethacin (75mg/day) in the symptomatic relief of RA patients. The possibility of the use of droxicam for the relief of morning stiffness is of particular interest.

A four-week open study was carried out to evaluate the efficacy and tolerability of droxicam, a new NSAID, in the treatment of painful osteoarthritis (OA). The results were compared with those obtained treating a similar group of patients with tenoxicam, at the same dosage of 20 mg/day, orally administered. The study showed that both drugs are effective in treating OA, with a mild predominance of droxicam in decreasing pain, functional limitation and chronic inability score. Tolerability was excellent or good in over 70% of patients and only one subject of each group was dropped out for severe side-effects. According to the Authors droxicam has shown to be an effective analgesic and anti-inflammatory agent as judged by its efficacy on pain relief and joint mobility in OA.

This double-blind clinical trial compares droxicam, a new non-steroidal anti-inflammatory agent and the reference compound diclofenac sodium. After a 7 day placebo run-in period, 80 patients with gonarthrosis and coxarthrosis were randomized to receive 20mg/day of droxicam and 150mg/day of diclofenac for 6 weeks. Evaluations were carried out at weeks 0 (placebo run-in), 2,3, and 6. Both drugs showed statistically significant improvements in all clinical measurements (index of severity, pain intensity, morning stiffness, maximal forced flexion and extension of the knee) after 6 weeks of treatment. Investigator's and patient's opinions were consistent with these results. The consumption of paracetamol was significantly lower amongst patients treated with droxicam. Withdrawals due to lack of therapeutic efficacy did not occur. A lower incidence of side effects, mostly upper gastrointestinal symptoms, was noticed amongst droxicam-treated patients. However, two patients in the droxicam group were withdrawn at week 3 and two days after week 6 because of epigastric pain and nausea, and cutaneous rash, respectively. Both study drugs are of benefit in reducing pain and improving joint motion and function in patients with coxarthrosis and gonarthrosis.

A controlled, randomized, double-blind, clinical trial has been performed in healthy volunteers in order to study the pharmacokinetics and tolerability of droxicam in comparison with piroxicam, when both drugs were administered at a dose of 20 mg/day for 20 days. Since transformation into piroxicam takes place in the gastrointestinal tract, unchanged droxicam was not detected in plasma. Steady state of plasma piroxicam concentrations was reached in all volunteers during the course of the study. Absorption kinetics of droxicam were delayed with respect to those of piroxicam (t1/2 a = 7.55 h for droxicam and 1.78 h for piroxicam). The remaining pharmacokinetical parameters studied showed no statistically significant differences. The bioavailability of both drugs was equal. Tolerability of droxicam and piroxicam was as usual for the NSAIDs, and no clinical or analytical side effects which could hinder its administration to wider populations were detected. Statistically significant differences in the number and type of side effects detected in the two treatment groups were not encountered.

The efficacy and safety of droxicam were compared with piroxicam in a pilot study in twenty patients with degenerative joint disease. After a one week washout period a baseline gastroscopy was carried out. Treatment during the following 4 weeks was randomised to droxicam or piroxicam. Safety and tolerance parameters were monitored at weekly intervals. Pain was evaluated with two visual analogue scales (VAS) (patient and investigator). Affected joints, articular index (AI), patient's status and a daily living activities questionnaire were also evaluated. Another gastroscopy was carried out at the end of the treatment period. Droxicam and piroxicam relieved all symptoms significantly without statistically significant clinical differences. Both groups showed no drug related side effects in the laboratory values. In the gastroscopic examinations two patients of the droxicam group and four of piroxicam group had minor gastric erosions after four weeks of treatment without any accompanying clinical symptoms.

Droxicam is a new anti-inflammatory drug which is a pro-drug of piroxicam and possesses delayed absorption kinetics. In this study, the comparative bioavailability of the two compounds was investigated. The study was performed following a cross-over design with single (20 mg) and multiple (20 mg/day for 30 consecutive days) administration in 25 healthy volunteers. The peak plasma concentrations of piroxicam, obtained following administration of droxicam, were lower than those calculated for administration of piroxicam, and the time taken to reach these peak concentrations was increased by approximately 5-7 h. There was no significant difference in either the elimination kinetics of piroxicam or the AUC values found following administration of the two products. Bioavailability of droxicam is equal to that of piroxicam, with a slower rate of absorption.