Evaluation of the efficacy, safety and tolerability of valdecoxib gel (1%) in adult patients with painful inflammatory joint disease

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, multic...

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Bibliographic Details
Published in:	Journal of the Indian Medical Association Vol. 101; no. 12; p. 764, 766, 727
Main Authors:	Jagtap, S A, Chincholi, Sanjeev, Taneja, Praveen Kumar, Ismail, N Deen Mohamed, Ram, S, Sarvagod, Shrikant B, Dongre, Neelesh, Desai, Anish
Format:	Journal Article
Language:	English
Published:	India 01-12-2003
Subjects:	Adolescent Adult Aged Cyclooxygenase Inhibitors - administration & dosage Cyclooxygenase Inhibitors - therapeutic use Female Humans Isoxazoles - administration & dosage Isoxazoles - therapeutic use Joint Diseases - drug therapy Male Middle Aged Pain Measurement Prospective Studies Sulfonamides - administration & dosage Sulfonamides - therapeutic use
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Summary:	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.
ISSN:	0019-5847