A Clinical Study to Evaluate the Safety and Efficacy of OLNP-27 versus placebo in Reducing Symptoms of Knee Osteoarthritis

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Male and female subjects 40 to 75 years of age

Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria)

Subjects with radio graphic evidence by Kellgren - Lawrence grade 2 or 3

Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy

VAS score during the most painful knee movement between 40-70 mm

Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs

Results of screening are within normal range or considered not clinically significant by the Principal Investigator

Drug naive subjects for OA treatment or subjects willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever including topical application (OTC or prescription) and Omega 3 fatty acids during the entire trial

Willing to sign the informed consent and comply with study procedure

Exclusion Criteria

Female subjects, who are pregnant, breast feeding or planning to become pregnant

Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication

History of underlying inflammatory arthropathy or severe RA or OA

Subjects scheduled for any surgery within 3 months of completing the study

Recent injury in the area affected by OA of the knee (past 4 months)

History of Gout

History of congestive heart failure

Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies

History of Systemic Lupus Erythematosus (SLE)

High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc)

History of psychiatric disorder that may impair the ability of subjects to provide written informed consent

Participation in any other trials involving investigational or marketed products within 30days prior to the Screening Visit

Have taken any corticosteroid, indomethacin, glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period