Feldene (Piroxicam) - Summary

FELDENE SUMMARY

FELDENE®
(piroxicam)
CAPSULES
10 mg and 20 mg
For Oral Use

FELDENE contains piroxicam which is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each maroon and blue capsule contains 10 mg piroxicam, each maroon capsule contains 20 mg piroxicam for oral administration.

Carefully consider the potential benefits and risks of FELDENE and other treatment options before deciding to use FELDENE. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

FELDENE is indicated:

• For relief of the signs and symptoms of osteoarthritis.
• For relief of the signs and symptoms of rheumatoid arthritis.

NEWS HIGHLIGHTS

Published Studies Related to Feldene (Piroxicam)

A clinical comparison of topical piroxicam and EMLA cream for pain relief and inflammation in laser hair removal. [2009.07]
The aim of this study was to compare the efficacy of topical piroxicam and EMLA cream on pain control and subsequent inflammation in neodymium:yttrium-aluminum-garnet (Nd:YAG) 1,064 nm laser hair removal in female volunteers. Fifty female volunteers were enrolled in this prospective, randomized, double-blind, clinical study over a 6-month period...

Efficacy and safety of piroxicam patch versus piroxicam cream in patients with lumbar osteoarthritis. A randomized, placebo-controlled study. [2009]
CONCLUSIONS: The piroxicam patch is effective in the treatment of lumbar osteoarthritis and has demonstrated to be well tolerated and it improves patients compliance. The piroxicam patch offers a comparable alternative to the marketed piroxicam cream for the treatment of lumbar osteoarthritis with the advantage of a better compliance with the once a day application of the patch compared to three daily applications for the piroxicam cream.

Double-blind, placebo-controlled, randomized clinical trial of sublingual or intramuscular piroxicam in the treatment of renal colic. A comparative study. [2007]
Aims: To investigate the therapeutic effect of the fast-dissolving dosage form (FDDF) of sublingual piroxicam on renal colic compared with the intramuscular (IM) injection form of the same agent in a randomized, double-blind, placebo-controlled clinical trial...

[Randomized study comparing piroxicam analgesia and tramadol analgesia during outpatient electromagnetic extracorporeal lithotripsy] [2006.04]
CONCLUSION: Piroxicam and tramadol are two analgesics commonly used in clinical practice and both are suitable for the treatment of pain during outpatient extracorporeal lithotripsy.

Sublingual piroxicam for postoperative analgesia: preoperative versus postoperative administration: a randomized, double-blind study. [2006.03]
Nonsteroidal antiinflammatory drugs have been used to obtain preemptive analgesia. We investigated, in this randomized, double-blind study, whether sublingual (s.l.) piroxicam given before was more effective than that given after surgery.Because of the low pain scores in both groups, the clinical relevance of these findings is not clear from this study.

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Clinical Trials Related to Feldene (Piroxicam)

A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg Twice Daily, As Needed In The First Menstrual Cycle Day And Then Once A Day, And Piroxicam 40 Mg Once A Day In The Treatment Of Patients With Primary Dysmenorrhea [Completed]
To compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in subjects with moderate to severe menstrual cramping pain associated with primary dysmenorrhea.

Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee [Recruiting]
this is a randomized double blinded trial which is conducted to measure the efficacy of topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard piroxicam gel.

Interaction Between Antihypertensives and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) [Completed]

Multi-Centre European Photopatch Test Study [Not yet recruiting]
It is known that people can develop an allergic skin reaction to a substance which is placed on the skin and then subjected to sunlight. This process is called Photocontact allergic dermatitis. It is known that people can develop Photocontact allergic dermatitis to sunscreen chemicals (filters) and also cream forms of pain-killing drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).

The purpose of this study is to determine the frequency of Photocontact allergic dermatitis to 19 sunscreen filters and 5 topical NSAIDs in 1,000 European patients who present to a dermatologist with a sun-exposed site dermatitis.

Each participant will have the 24 test agents plus one control of petrolatum applied to the skin of the back for 24 or 48 hours. After removal of the substances, the area of skin will be exposed to a precise amount of ultraviolet-A light. The area is then assessed 24, 48 and 72 hours later to see if a photocontact allergic reaction has occured. This method is known as photopatch testing.

The study will run for one year, during which time it is planned to recruit 1,000 patients.

Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy [Completed]
To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.

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