Health Condition 1: null- Osteoarthritis of knee
Conditions
Interventions
Intervention1: Dynapar QPS (Diclofenac diethylamine 4.64% w/v topical solution): 5 sprays QID for 6 weeks
Each pump spray (0.1 ml) will deliver 4.64 mg of diclofenac diethylamine, equivalent to 4 mg o
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender, 40-65 years of age 2.Patient fulfilling modified American College of Rheumatology (ACR) criteria for osteoarthritis of knee 3.Patients on frequent oral analgesic treatment (at least 3 days per week during the previous 4 weeks) for at least past 4 weeks for the management of symptomatic unilateral or bilateral primary osteoarthritis of knee at the time of screening 4.Patients with at least moderate intensity of pain (defined as score of greater than or equal to 4 on 10 point visual analogue scale) while performing a weight-bearing activity e.g. walking, standing, climbing stairs during or at the end of washout period after screening
Exclusion criteria
Exclusion criteria: 1.History of major trauma or surgery in the study joint within previous 6 months at the time of screening 2.History of acute inflammatory arthritis, pseudogout or crystal deposition disorder of the study knee joint 3.Radiographic evidence suggestive of arthritis other than primary osteoarthritis 4.Patients receiving prescription muscle relaxants, psychotropic agents (except tramadol) corticosteroids or any other drug affecting the evaluation of analgesic action; or taking supplements like glucosamine and chondroitin sulfate. 5.Patients with alternative form of therapy i.e. physical manipulation, acupuncture etc. 6.Intramuscular corticosteroids in past 4 weeks or; oral or topical corticosteroids in past 2 weeks at the time of screening 7.Intra-articular injection of any drug within past 4 weeks at the time of screening 8.Patients with history of cardiovascular surgery i.e., coronary artery bypass graft or Percutaneous coronary intervention, within past 4 weeks at the time of screening 9.Patients who require or scheduled for any surgery (including knee joint surgery) during study period 10.Uncontrolled systemic disorders like diabetes mellitus, hypertension, or cardiac disorder requiring hospitalization 11.Renal or hepatic impairment as per following laboratory parameters, •Serum creatinine greater than upper limit of normal; •SGOT or SGPT greater than 3 times upper limit of normal 12.Patients requiring hospitalization during the study period 13.Skin disorder at the site of study drug application 14.Use of other topical medicines at the same site of study drug application 15.Known case of gastrointestinal bleeding or peptic ulcer disease 16.History of bronchial asthma, bronchitis or any other contraindication to study drugs 17.Known hypersensitivity to NSAIDs or history of hypersensitivity to any topical medication 18.Patients on any form of anticoagulation therapy 19.Pregnant and lactating women 20.Women of child bearing potential, not practicing or not willing to use contraceptive method during study period unless patient had undergone hysterectomy 21.Patient unwilling or incapable of giving informed consent or to comply with study procedures 22.Patients having participated in any clinical trial within last 30 days at the time of screening 23.Previous participation in this study 24.Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change from baseline in WOMAC index sub score for pain â?¢ Change from baseline in VAS Score for pain intensity on weight bearing activity Timepoint: Day 1, 7, 14, 28 and 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the WOMAC index sub scores other than pain e.g. stiffness and physical functionTimepoint: Day 1, 7, 14, 28 and 42;Change in adverse events with pre-enrollment systemic analgesic therapy after initiation of study medicationTimepoint: Day 1;Change in vitalsTimepoint: Day 1, 7, 14, 28 and 42;Clinical laboratory parameter abnormalityTimepoint: During screening and on day 42;Global assessment of efficacy by patients and investigatorTimepoint: Day 42;Global assessment of tolerability by patients and investigatorTimepoint: Day 42;Local adverse eventsTimepoint: Day 1 to 42;Mean number of days for which patient required rescue analgesic during the study periodTimepoint: Day 1 to 42;Mean number of tablets of rescue analgesic required during the study periodTimepoint: Day 1 to 42;Proportion of patients requiring rescue analgesia for greater than or equal to 50% (greater than or equal to 21 days) of study periodTimepoint: Day 1 to 42;Systemic adverse eventsTimepoint: Day 1 to 42 | — |
Countries
India
Contacts
Public ContactDr Agam Shah
Troikaa Pharmaceuticals Limited
Outcome results
None listed