Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee
Brief Summary: This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment.

A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)


Options:
A: Inclusion Criteria:

* Osteoarthritis of the knee

Exclusion Criteria:

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
* Other protocol defined inclusion/exclusion criteria may apply.
B: Main Inclusion Criteria:

* Male or female patients aged at least 40 years.
* Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system.
* Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening.
* pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated.

Main Exclusion Criteria:

* Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain
* Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned.
* Female patients who are pregnant or breast-feeding.
C: 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
D: Key Inclusion criteria:

• Osteoarthritis of the hand

Key Exclusion Criteria:

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs

Answer: B