Intervention: Prednisolone
Trial phase: Phase 2
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Prednisolone 2.7 mg
Eligibility criteria:
Inclusion Criteria:

Subject must voluntarily give written informed consent
Subject must be ≥ 40 years of age
Knee pain for at least 6 months requiring NSAIDs or Coxibs for analgesia on the majority of days (≥ 15 days) during the preceding month
WOMAC pain score when walking on a flat surface (question #1) between 30-80 mm at Screening with at least a 10 mm increase following NSAID or Coxib discontinuation during the Screening period
Radiographic evidence of knee OA (Kellgren-Lawrence grade 2 or 3)
Functional class I, II, or III according to the American Rheumatism Association
Subject willing to take a multivitamin or the equivalent of at least 400 IU vitamin D and the equivalent of at least 1000 mg of elemental calcium daily

Exclusion Criteria:

Predominant patellofemoral disease or clinically significant trauma to index knee
History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, osteoporotic and/or other major disease
History of malignancy within the past 10 years (except for excised or treated basal cell or fewer than 3 squamous cell skin carcinomas)
History of lymphoma or chronic leukemia
Moles or lesions that are currently undiagnosed, but are suspicious for malignancy
Surgery within the previous 3 months (except for minor dental, and/or cosmetic procedures)
History of drug or alcohol abuse (as defined by the Investigator)
History of bleeding disorder
History of GI bleeding within 5 years of Screening
History of severe migraines or headaches
History of glaucoma
Visually compromising cataract
Active diabetic retinopathy
History of osteoporotic fracture
History of opportunistic infection
Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to Screening
Fever or symptomatic viral or bacterial infection within 2 weeks prior to Screening
Positive for hepatitis C (HCV) antibody
Positive for hepatitis B surface antigen (HBsAg)
Known positive history for human immunodeficiency virus (HIV) antibody
Surgery on the index knee within 1 year of Screening
History of hypersensitivity to steroids or dipyridamole
Treatment with oral, intramuscular, or intravenous glucocorticoids within 6 weeks prior to Screening; intra-articular glucocorticoids within 10 weeks prior to Screening; inhaled glucocorticoid is permitted
Treatment with injectable hyaluronic acid within 3 months of Screening
Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days prior to Screening
Treatment with NSAIDs (oral or topical), Coxibs or topical capsaicin
Treatment with anticoagulants including: dipyridamole, warfarin, clopidogrel, ticlopidine, or ASA > 81 mg per day
Treatment with any concomitant medications that have not been at a stable dose for at least 28 days prior to Screening
Treatment for osteoporosis such as bisphosphonates (e.g., Fosamax®, Actonel®), or teriparatide (e.g., Forteo®), or calcitonin (e.g., Miacalcin, Calcimar) must be at stable dosages for at least 3 months prior to Screening
ALT or AST laboratory values >1.5 X the ULN
HgbA1c value of >7.0%
Current enrollment in any other study with investigational drug or device
Female subject who is pregnant or lactating
Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment