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 - Safety and efficacy of two dosages of Diractin in OA

Phase 1

Conditions: Treatment of osteoarthritis of the knee
MedDRA version: 9.1 Level: LLT Classification code 10031161 Term: Osteoarthritis

Registration Number: EUCTR2006-006298-26-GB

Lead Sponsor: IDEA AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 1320

Inclusion Criteria

•Informed consent signed and dated
•Age older than 45 years (if age of 18-45, radiological confirmation of
diagnosis of knee OA is required)
•Subject has a primary diagnosis of Functional Class I-III OA of the knee
and subject meets American College of Rheumatology (ACR) clinical
classification criteria for osteoarthritis of the knee, defined by the following:

Knee pain and at least 4 of the following 6:
oAge >50
oMorning stiffness <30 minutes
oCrepitus on active motion
oBony tenderness
oBony enlargement
oNo palpable warmth of synovium
•Patient able to identify a predominantly painful (index) knee
•Mild to moderate pain defined by pain on walking on a flat surface of the
index knee defined by question 1 of the WOMAC rated = 4 and a total
average WOMAC pain subscale of < 7 at B1 and B2
•If female, subject is either not of childbearing potential (defined as
postmenopausal for at least one year or surgically sterile [bilateral tubal
ligation, bilateral oophorectomy or hysterectomy]) or subject is of
childbearing potential and practicing one of the following methods of birth
control:
ototal abstinence from sexual intercourse (minimum one complete
menstrual cycle before study entry),
oa vasectomized partner,
ocontraceptives (oral, parenteral, or transdermal) for three consecutive
months prior to investigational product administration,
ointrauterine device (IUD), or
odouble-barrier method (condoms, sponge, diaphragm or vaginal ring with
jellies or cream).
•If female of childbearing potential, subject has a negative urine pregnancy
test at screening and B2.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Difference in WOMAC pain rating for question 1 or the total average pain
score between B1 and B2 > 2
•Skin lesions or dermatological diseases in the treatment area
•Extreme obesity (BMI > 37)
•Directly or indirectly involved in the conduct and administration of this
study (i.e. principal investigator, sub-investigator, study co-ordinators,
other study staff, employees of IDEA AG, IDEA contractors and/or their
families)
•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
•Morbus Meulengracht/Gilbert syndrome
•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, omeprazole, paracetamol
and to ingredients of the IMP including galactose
•Preexisting asthma bronchiale or bronchospasm after taking aspirin or
other NSAIDs
•Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis,
gout of the index knee, pseudogout, systemic lupus erythematodes, or
mixed connective tissue disease
•Symptomatic ipsilateral hip OA or predominant retropatellar knee OA
•Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants
including low dose aspirin
•Ischemic heart disease requiring drug therapy
•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 = 5 times the ULN

•Within 3 months prior or during the study
oIntraarticular injections of hyaluronic acid products in the index knee
oArthroscopy of the index knee
oTricyclics
• Within 2 months prior or during the study
oOral, inhaled or parenteral corticosteroids (depot steroids 6 months)
oChange in oral treatment regimen of glucosamine, chondroitin sulfate,
shark cartilage, methylensulfonylmethan (MSM), Vitamin E, diacerin or
nutraceuticals
•Within 1 month prior or during the study
oIntraarticular injections of corticosteroids in the index knee within 1
months prior to screening or during the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of two dosages of Diractin® (50 mg, 100 mg ketoprofen in Transfersome® gel) in patients with mild to moderate pain related to osteoarthritis (OA) of the knee.;Secondary Objective: To evaluate the overall safety of two dosages of Diractin® (50 mg, 100 mg ketoprofen in Transfersome® gel) in patients with mild to moderate pain related to OA of the knee.;<br> Primary end point(s): The primary efficacy endpoint is:<br> •Change from baseline at Week 12 on the entire pain subscale of the<br> WOMAC (NRS)<br>

Secondary Outcome Measures

Name	Time	Method

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