Health Condition 1: null- Osteoarthritis of the Hip, Knee and Hand
Conditions
Interventions
Intervention1: Etodolac gel: TID, Topical for 6 weeks
Control Intervention1: Volini gel: TID, Topical for 6 weeks
Control Intervention2: Placebo: TID, Topical for 6 weeks
Sponsors
University Institute of Pharmaceutical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female of age >= 18. 2. Must be in generally good health as confirmed by medical and previous medication history, and baseline physical examination including vital signs. 3. Symptomatic osteoarthritis of the target hip or knee joint as evidenced by hip or knee pain for at least 3 months (for at least 20 days of each month) and osteophytes confirmed by an x-ray taken within the last two years 4. After a full explanation of the study, subjects must understand the nature of the study and sign the informed consent form to participate. 5. Patients must have osteoarthritis of knees, hip and hands for a minimum of six months - have moderate pain in the most involved area when not taking non-steroidal anti-inflammatory drugs (NSAIDs). 6. Demonstrate x-ray evidence of osteoarthritis in the most involved areas during the preceding six months Patient who also meet two of the following three clinical criteria: a) Morning stiffness of, 30 minutes duration, crepitus on motion. b) Rating their pain in the index knee as >3 on a five-point Likert scale. c) Taking oral NSAIDs at least 3 days per week for the past 3 months or for >25 of the past 30 days. Moreover, patients had to meet three osteoarthritis flare criteria: a) Pain in the index knee on walking >40 mm on a visual analogue scale (VAS). b) Increased by >15 mm compared with pain on pre-study treatment (screening). c) Patient global assessment (PGA) score for osteoarthritis of 3â??5 and at least one grade increase from screening.
Exclusion criteria
Exclusion criteria: 1. Patient receiving physical therapy to either knee or having a history of allergy, hypersensitivity or contraindication to NSAID. 2. Pregnant or lactating females 3. Open wounds, infected skin or fractures 4. Opiod use within 7 days 5. Prior topical medication applied to the painful region/area of study 6. Subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain (e.g. arthroscopic techniques, osteotomy, joint replacement surgery, etc.). 7. Subjects who are experiencing another type of continuous pain that is more severe in intensity in comparison with the OA target joint pain (e.g. low back pain, fibromyalgia, ankylosing spondylitis, etc.). 8. Subjects with a significant psychiatric disorder (including major depression) or subjects receiving anti-psychotic medication. 9. Subjects who have taken sedatives, hypnotics, phenothiazines, anticonvulsants, tranquilizers or muscle relaxants two weeks preceeding study entry. These medications cannot be started during the study. 10. Subjects with documented or suspected history of alcohol or drug abuse, or who have a documented or suspected history of an addictive personality. 11. Have a history of partial or total knee replacement in either knee, or have a history of gout, pseudo-gout induced synovitis, or infection of the more severe knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean fall in five point scale of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index from the baselineTimepoint: 0, 1, 2, 4, 6 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean fall in five point scale of Patient Global Assessment from the baselineTimepoint: 0, 1, 2, 4, 6 week | — |
Countries
India
Contacts
Public ContactMr Kaisar Raza
University Institute of Pharmaceutical Sciences Panjab University
Outcome results
None listed