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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 [2013 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 [2611 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...

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...

Cost-effectiveness of generic celecoxib in knee osteoarthritis for average-risk patients: A model-based evaluation.

The cost-effectiveness of the recently-introduced generic celecoxib in knee OA has not been examined.

Optical Detection of Ketoprofen by Its Electropolymerization on an Indium Tin Oxide-Coated Optical Fiber Probe.

In this work an application of optical fiber sensors for real-time optical monitoring of electrochemical deposition of ketoprofen during its anodic oxidation is discussed. The sensors were fabricated ...

Efficacy and Safety of Single-Dose OnabotulinumtoxinA in the Treatment of Symptoms of Osteoarthritis of the Knee: Results of a Placebo-Controlled, Double-Blind Study.

To evaluate intraarticular onabotulinumtoxinA 400 U and 200 U in reducing symptoms of knee osteoarthritis (OA) in patients with nociceptive pain.

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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