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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Osteoarthritis of the Knee
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT00716547
Primary Trial ID Number
Summary
The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.
Research Details
  • 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.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : ketoprofen in Diractin®, Drug : ketoprofen in Diractin®, Drug : Placebo, Drug : celecoxib

Study Arm Groups : 1, 2, 4, 3

Intervention Type
See Interventions above
Primary Outcome Measures
  • pain subscale of the WOMAC; week 12
Secondary Outcome Measures
  • Patient global assessment of response to therapy; week 12; function subscale of the WOMAC; week 12
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
46 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Informed consent signed and dated
  • - Age > 45 years
  • - Class I-III OA of the knee and subject meets American College of Rheumatology (ACR)
  • clinical classification criteria for osteoarthritis of the knee
  • Exclusion Criteria:
  • - Skin lesions or dermatological diseases in the treatment area
  • - Directly or indirectly involved in the conduct and administration of this study
  • - Received any investigational medicinal product within 30 days prior to Screening
  • Visit or participation in any previous clinical study with Diractin®
  • - Pregnancy or lactation
  • - Residents of psychiatric wards, prisons or other state institutions
  • - Malignancy within the past 2 years
  • - Depressive disorders requiring treatment with tricyclics, treatment with other
  • antidepressants must be stable for 3 months prior to screening and throughout the
  • study
  • - Epilepsy
  • - Schizophrenia
  • - Neuropathic pain and any other pain condition requiring chronic use of pain
  • medication
  • - Known hypersensitivity or allergy (including photoallergy) to NSAID´s including
  • ketoprofen, celecoxib, sulfonamides and ingredients used in pharmaceutical products
  • including galactose
  • - Peripheral arterial disease and/or cerebrovascular disease
  • - History of stroke or myocardial infarction
  • - Congestive Heart failure NYHA Class II-IV
  • - History of pancreatitis or peptic ulcers;
  • - Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
  • - Serum creatinine levels > 2.5 milligrams/deciliter (mg/dL)
  • - ALT or AST levels ≥ 5 times the ULN
  • - Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle
  • relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs
  • approved or used for the treatment of pain for the duration of the study
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Research Site
Leeds
LS7 4SA
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Czech Republic, Germany, Poland, United Kingdom
Scientific Title
Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CL-033-III-03
Sponsor(s)
IDEA AG
Key Dates

Recruitment Start Date

May 2008

Recruitment End Date

Mar 2009

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

14 Jul 2008

Last Updated

15 Oct 2009