CTRI/2022/01/039859
Not yet recruiting
未知
A Randomized, Double Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of OLNP-27 versus placebo in Reducing Symptoms of Knee Osteoarthritis
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Olene Life Sciences Private Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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