A clinical trial to study the effects of two drugs, Dynapar QPS and placebo topical solution in patient suffering from osteoarthritis.

Phase 3

Completed

• Conditions: Osteoarthritis of knee

• Registration Number: CTRI/2015/02/005510
• Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary

This study is a prospective, randomized, double blind, two arm, parallel, placebo controlled, comparative, multicentre clinical study to evaluate the safety and efficacy of Dynapar QPS (5 sprays, QID) compared to placebo (5 sprays, QID) topical solution in 212 patients with osteoarthritis of knee, that will be conducted in 8 centers in India. **The primary outcome** measures will be Change from baseline in WOMAC index sub score for pain on week 1, 2, 4 and 6. Change from baseline in VAS Score for pain intensity on weight bearing activity will also be assessed on week 1, 2, 4 and 6. **The secondary outcome** measured will be Change from baseline in the WOMAC index sub scores other than pain e.g. stiffness and   physical function on week 1, 2, 4 and 6. Mean number of tablets of rescue analgesic required during the study period on week 1, 2, 4 and 6. Mean number of days for which patient required rescue analgesic during the study period on week 1, 2, 4 and 6. Proportion of patients requiring rescue analgesia for ≥ 50% (≥ 21 days) of study period. The Global assessment of efficacy by patients and investigator will be done at week 6.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-25
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 212

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Change from baseline in WOMAC index sub score for pain	Day 1, 7, 14, 28 and 42
• Change from baseline in VAS Score for pain intensity on weight bearing activity	Day 1, 7, 14, 28 and 42

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the WOMAC index sub scores other than pain e.g. stiffness and physical function	Day 1, 7, 14, 28 and 42
Mean number of tablets of rescue analgesic required during the study period	Day 1 to 42
Mean number of days for which patient required rescue analgesic during the study period	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 period	Day 1 to 42
Global assessment of efficacy by patients and investigator	Day 42
Change in vitals	Day 1, 7, 14, 28 and 42
Change in adverse events with pre-enrollment systemic analgesic therapy after initiation of study medication	Day 1
Local adverse events	Day 1 to 42
Systemic adverse events	Day 1 to 42
Clinical laboratory parameter abnormality	During screening and on day 42
Global assessment of tolerability by patients and investigator	Day 42

Trial Locations

Locations (8)

Apollo Gleneagles Hospitals; 🇮🇳 Kolkata, WEST BENGAL, India

Apollo Hospitals Educational and Research Foundation; 🇮🇳 Chennai, TAMIL NADU, India

Fortis Flt. Lt. Rajan Dhall Hospital, Delhi; 🇮🇳 Delhi, DELHI, India

Inamdar Mutlispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Sapthagiri Institute of Medical Sciences and Research Center; 🇮🇳 Bangalore, KARNATAKA, India

Seth GS Medical College & KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Sheth VS general Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

St.Johns Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Apollo Gleneagles Hospitals

🇮🇳Kolkata, WEST BENGAL, India

Dr Ranadeep Rudra

Principal investigator

9831575497

rudra_ortho@hotmail.com