title: Evaluation of the efficacy, safety and tolerability of valdecoxib gel (1%) in adult patients with painful inflammatory joint disease.
abstract: Valdecoxib, a COX-2 inhibitor, has recently been introduced as a gel formulation. The present study was conducted to evaluate the efficacy, safety and tolerability of valdecoxib gel in adult patients with painful inflammatory joint conditions. The present study was a 10-day prospective, open, multicentric (6 centres) trial. Patients with clinical and radiological diagnosis of painful inflammatory joint conditions were treated with valdecoxib gel (1%). Efficacy was assessed by visual analogue scale (VAS), patient's and physician's global assessment of pain relief. Grading of associated clinical manifestations such as stiffness, swelling, tenderness and restriction of mobility was done. Tolerability and safety was assessed by physical examination, laboratory parameters and evaluation of adverse events. There was a statistically significant decrease in the mean pain visual analogue score (p<0.05). Onset of pain relief was within 15 minutes. There was a reduction of 58.8%, 57.2%, 65.4% and 60.2% in mean scores of stiffness, swelling, tenderness and mobility respectively from the baseline which was statistically significant. The laboratory values were within normal limits. The drug was well tolerated. There was no report of any hypersensitivity reaction. This study confirms that valdecoxib gel (1%) is an effective and safe option for the management of painful inflammatory joint conditions.
authors.affiliation: Sir JJ Group of Hospitals and Grant Medical College, Mumbai 400008.
authors.forename: S A
authors.initials: SA
authors.lastname: Jagtap
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Chincholi
authors.forename: Praveen Kumar
authors.initials: PK
authors.lastname: Taneja
authors.forename: N Deen Mohamed
authors.initials: ND
authors.lastname: Ismail
authors.forename: S
authors.initials: S
authors.lastname: Ram
authors.forename: Shrikant B
authors.initials: SB
authors.lastname: Sarvagod
authors.forename: Neelesh
authors.initials: N
authors.lastname: Dongre
authors.forename: Anish
authors.initials: A
authors.lastname: Desai
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D007592:Joint Diseases / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D000096926:Benzenesulfonamides
chemical_list: D016861:Cyclooxygenase Inhibitors; D007555:Isoxazoles; D013449:Sulfonamides; C406224:valdecoxib; D000096926:Benzenesulfonamides