PROSPECTIVE, SINGLE ARMSTUDY TO DETERMINE THE SAFETY AND EFFICACY OF TOPICAL DICLOFENAC SODIUM GEL WITH NANOTECHNOLOGY IN SUBJECTSWITH OSTEOARTHRITIS OF KNEE

Not Applicable

Completed

• Conditions: Health Condition 1: null- SUBJECTS WITH OSTEOARTHRITIS OF KNEE

• Registration Number: CTRI/2015/10/006269
• Lead Sponsor: Mrs Nagalakshmi AnandaPadmanabhan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

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 and a baseline pain subscale of at least 9.

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

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

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 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in the Pain Index score in target knee from baseline to <br/ ><br>week 4 <br/ ><br>· Mean change in pain on movement (POM) on a Visual Analog Scale <br/ ><br>(VAS) for target knee from baseline to week 4 <br/ ><br>· Mean change in Patient Global Assessment (PGA) score from baseline <br/ ><br>to week 4Timepoint: 30 Days

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with adverse events (AEs) and serious adverse <br/ ><br>events <br/ ><br>· Changes in physical examination, vital signs, and clinical laboratory <br/ ><br>tests (hematology and biochemistry parameters) from baseline to week <br/ ><br>4Timepoint: 4 weeks