CTRI/2017/06/008874尚未招募未知
A Randomized, Double Blind, Placebo Controlled,Parallel-Group Study to Evaluate the Safety and Efficacyof OLNP-08 versus placebo in Reducing Symptoms ofKnee Osteoarthritis
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female subjects 40 â?? 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2.
- •2. Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria)
- •3. Subjects with radio graphic evidence by Kellgren - Lawrence grade 2 or 3
- •4. 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
- •5. VAS score during the most painful knee movement between 40-70 mm
- •6. Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs
- •7. Results of screening are within normal range or considered not clinically significant by the Principal Investigator
- •8. Drug naive subjects 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.
- •9. Willing to sign the informed consent and comply with study procedure
排除标准
- •1. Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •2. 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
- •3. History of underlying inflammatory arthropathy or severe RA or OA
- •4. Subjects scheduled for any surgery within 3 months of completing the study
- •5. Recent injury in the area affected by OA of the knee (past 4 months)
- •6. History of Gout
- •7. History of congestive heart failure
- •8. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, ngastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies
- •9. History of Systemic Lupus Erythematosus (SLE)
- •10. High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc)
- •11. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
- •12. Participation in any other trials involving investigational or marketed products within 30days prior to the Screening Visit
- •13. 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.
研究者
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