Roth S.H.,Arizona Research and Education |
Fuller P.,Mallinckrodt Inc
Clinical Interventions in Aging | Year: 2012
Background: This study aimed to determine the safety of diclofenac sodium topical solution 1.5% (w/w) in 45.5% dimethyl sulfoxide (TDiclo) for the treatment of knee or hand osteoarthritis in persons aged 75 years or older. Methods: A pooled analysis of safety data from seven multicenter, randomized, blinded, Phase III clinical trials (4-12 weeks' duration) of TDiclo was conducted. The analysis focused on a subset of patients (n = 280) aged 75 years or older with a primary diagnosis of osteoarthritis of the knee (six trials) or hand (one trial). Patients received one of three topical treatments: TDiclo (n = 138); placebo (2.33% or 4.55% dimethyl sulfoxide, n = 39); or control (45.5% dimethyl sulfoxide, n = 103). Treatment groups were compared using Chi-square analysis, Fisher's Exact test, or analysis of variance. Results: The most common adverse events involved the skin or subcutaneous tissue, primarily at the application site. The incidence of dry skin was higher in the TDiclo (36.2%; P < 0.0001) and dimethyl sulfoxide control (18.4%; P = 0.0142) groups than in the placebo group (2.6%); the incidence of other skin or subcutaneous tissue adverse events was similar between the groups. Relatively few patients (<18%) experienced gastrointestinal adverse events, and group differences were not detected. In the TDiclo group, constipation (3.6%), diarrhea (3.6%), and nausea (3.6%) were the most common gastrointestinal adverse events. Cardiovascular and renal/urinary adverse events were rare, and group differences were not detected. There was one case (0.7%) each of hypertension, spider veins, and vasodilation in the TDiclo group. Changes from baseline to the final visit in blood pressure and hepatic/renal enzyme levels were also similar between the groups. Conclusion: TDiclo appears to be well tolerated for the treatment of osteoarthritis in persons aged 75 years or older. © 2012 Roth and Fuller, publisher and licensee Dove Medical Press Ltd.
Mallinckrodt Inc | Date: 1999-11-30
Mallinckrodt Brand Pharmaceuticals Inc., Mallinckrodt Baker Inc., Mallinckrodt Tmh, Mallinckrodt Tmh Mallinckrodt Medical Inc. and Mallinckrodt Inc. | Date: 1997-07-29
full line of pharmaceutical preparations; in vitro pharmaceutical diagnostic preparations for medical use; a full line of diagnostic and therapeutic preparations and substances for in vivo use; a full line of contrast media for medical imaging; a full line of pre-filled syringes containing contrast media for use in medical diagnostic procedures. surgical and medical instruments and components thereof, namely, a full line of syringes, tracheal tubes, tracheostomy tubes, bronchial tubes, temperature probes, temperature monitoring instruments, respiratory therapy apparatus, catheters, blood analyzing apparatus, physiologic monitors for monitoring vital signs, fluid delivery systems, medical generators, intravascular apparatus, electrolyte analyzing apparatus, cardiac output apparatus, ventilator support apparatus, drug and fluid infusion pumps, patient warming apparatus and blankets specially designed for surgical, post-surgical and other medical use, anesthesiology delivery apparatus, respiratory filters, respiratory heat and moisture exchange apparatus.