This is a clinical trial to compare clinical efficacy, safety and tolerability of generic Diclofenac Sodium Topical Gel 1%, with VoltarenÂ® Gel (a Diclofenac Sodium Topical Gel 1%) and Vehicle of Diclofenac Sodium Topical Gel 1% in subjects with osteoarthritis(degenerative joint disease) of the knee

Not Applicable

Completed

Conditions: Health Condition 1: M17- Osteoarthritis of knee

Registration Number: CTRI/2015/09/006149

Lead Sponsor: Cipla Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 990

Inclusion Criteria

A subject will be eligible for inclusion in the study if he / she fulfils the following criteria:

1.Male or non-pregnant female aged >= 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria:

a.Pain in the knee and presence of at least 3 of the following ACR criteria: age >= 50 years; stiffness lasting for < 30 min; bony tenderness; crepitus; bony enlargement; no palpable warmth, and including:

i.Symptoms for at least 6 months prior to screening, and

ii.Knee (not referred) pain for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.), and

iii.The pain in the target knee required the use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen / paracetamol (topical or oral treatments)

2.Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease

3.After discontinuing all pain medications for at least 7 days, had at least moderate POM for target knee, defined as a baseline score of >= 50 mm on a 0-100 mm VAS immediately prior to randomization, and a baseline WOMAC pain subscale of at least 9 immediately prior to randomization

4.Able to tolerate rescue medication (i.e., acetaminophen / paracetamol)

5.Subjects willing to refrain from using any other OA treatment during the 4-week treatment period, other than the study treatment, and rescue medication

6.Subjects willing to give written informed consent and provide audio-visual recording of the consent process

7.Willing and able to comply with the study requirements

8.Not pregnant / not planning to be pregnant / not a lactating female. Women of childbearing potential and male subjects were included in the study if they are willing to use an appropriate method of contraception

Exclusion Criteria

A subject will not be eligible for inclusion in this study if he / she meets any of the following criteria:

1.X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease

2.History of OA pain in the contralateral knee requiring medication within 1 year prior to screening

3.After discontinuing all pain medications for at least 7 days, had a baseline score of >= 20 mm on a 0-100 mm VAS for the contralateral knee immediately prior to randomization

4.History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia

5.History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease

6.History of gastrointestinal (GI) bleeding or peptic ulcer disease

7.Known allergy to aspirin or NSAID

8.Elevated transaminases at screening (i.e., AST or ALT more than 2 times the upper limit of normal at screening visit)

9.Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within the past 30 days prior to entry into the study

10.Concomitant acetyl salicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162 mg daily) taken for at least 3 months prior to enrolment and maintained throughout the duration of the study

11.Any other topical products applied to the target site

12.Use of systemic corticosteroid or immunosuppressive drugs

13.Use of pain medication other than acetaminophen / paracetamol

14.Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of the study data or place the subject at risk by participating in the study

15.Receipt of any drug as a part of a research within 30 days prior to screening

16.Previous participation in this study

17.Recent history of knee injury or surgery

18.Subjects who are alcohol or drug dependent i.e. substance of abuse

19.Subjects having clinically significant liver, kidney, or cardiac dysfunction

20.Subjects having history of hypersensitivity reactions to diclofenac sodium gel or any of its excipients

21.A positive serology test result for HIV antibody (I & II), HBsAg, and / or HCV antibodies

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint of the study is: <br/ ><br>Mean change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score in target knee from baseline to week 4.Timepoint: 4 weeks.

Secondary Outcome Measures

Name	Time	Method
The Safety endpoints of the study are: <br/ ><br>Proportion of subjects with adverse events (AEs) and serious adverse events. <br/ ><br> <br/ ><br>Change in physical examination, vital signs, and clinical laboratory tests (hematology and biochemistry parameters) from baseline to week 4. <br/ ><br>Timepoint: 4 weeks.;The secondary efficacy endpoints of the study are: <br/ ><br>Mean change in pain on movement (POM) on a Visual Analog Scale (VAS) for target knee from baseline to week 4. <br/ ><br> <br/ ><br>Mean change in patient global assessment (PGA) score from baseline to week 4. <br/ ><br>Timepoint: 4 weeks.