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Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

2014-08-27 03:29:02 | BioPortfolio

Summary

The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.

Description

The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Osteoarthritis of the Knee

Intervention

ketoprofen in Diractin®, ketoprofen in Diractin®, Placebo, celecoxib

Location

IDEA Investigational Site
Prague 2
Czech Republic
128 50

Status

Completed

Source

IDEA AG

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:29:02-0400

Clinical Trials [2112 Associated Clinical Trials listed on BioPortfolio]

Multi-Centre, Open-Label, Two Segment, Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise

- Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg applied on 2 major joints to - 400 mg ketoprofen from Diractin® (100 mg applied to 4 j...

Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee

The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.

Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee

The purpose of this study is to determine the safety and effectiveness of 110 mg ketoprofen in Transfersome applied to the skin twice daily as compared to placebo and oral celecoxib 200 mg...

Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee

The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for t...

Trial to Evaluate the Efficacy of ThermoProfen (Matrix Transdermal Ketoprofen/CHADD™ System) in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee

ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with ...

PubMed Articles [2508 Associated PubMed Articles listed on BioPortfolio]

Molecular State of Active Pharmaceutical Ingredients in Ketoprofen Dermal Patches Characterized by Pharmaceutical Evaluation.

The molecular states of ketoprofen and the interaction between ketoprofen and other pharmaceutical excipients in the matrix layer were examined to determine their effect on the pharmaceutical properti...

Topical Ketoprofen Versus Placebo in Children Presenting With Ankle Sprain to the Emergency Department: A Randomized Controlled Study.

Despite the favorable data concerning topical agents use in outpatient clinics, they are not commonly in emergency departments (EDs). The present study aimed to compare the effect of 2.5% topical keto...

Ketoprofen and MicroRNA-124 Co-loaded poly (lactic-co-glycolic acid) Microspheres Inhibit Progression of Adjuvant-induced Arthritis in Rats.

Ketoprofen, a non-steroid anti-inflammatory drug, is widely used for relieving the pain and swelling caused by rheumatoid arthritis. However, ketoprofen can't suppress disease progression effectively....

Efficacy of Ketoprofen With or Without Omeprazole for Pain And Inflammation Control After Third Molar Removal.

In view of the gastrointestinal problems generated by the ketoprofen use, the ketoprofen association with omeprazole is available on the market. However, this association efficacy in acute pain contro...

Developmental toxicity and biological responses of zebrafish (Danio rerio) exposed to anti-inflammatory drug ketoprofen.

Ketoprofen a nonsteroidal anti-inflammatory drug (NSAID) is widely used in over-the-counter to treat pain, swelling and inflammation. Due to extensive application these drugs has been detected in surf...

Medical and Biotech [MESH] Definitions

An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.

A pyrazole derivative and selective CYCLOOXYGENASE 2 INHIBITOR that is used to treat symptoms associated with RHEUMATOID ARTHRITIS; OSTEOARTHRITIS and JUVENILE ARTHRITIS, as well as the management of ACUTE PAIN.

Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)

An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.

Injuries to the knee or the knee joint.

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Relevant Topics

Pain
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Arthritis
Arthritis is by definition the inflammation of one or more joints, characterized by swelling, pain, warmth, redness and diminished range of joint movement (Oxford Medical Dictionary). There are many different types; Noninflammatory; Osteoarthritis, N...


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