How is GMERS Junagadh for an MBBS

Study comparing a generic diclofenac sodium topical gel, 1% with Voltaren in the treatment of patients with osteoarthritis of the knee

Inclusion criteria:

- Healthy outpatient male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.

- Had a target knee x-ray taken no more than 1 year prior to study entry, evidence of OA with Grade 1-3 Kellgren-Lawrence Disease.

- After stopping all pain relievers for at least 7 days, have at least moderate movement pain for the target knee

- If you are female and of childbearing potential, agree not to have sexual intercourse or use an effective method of contraception during the study

- Can tolerate paracetamol / paracetamol emergency medication.

Exclusion criteria:

- Pregnant or breastfeeding, or planning to become pregnant during the study period.

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

- A history of OA pain in the contralateral knee that is required for screening within one year prior to taking medication.

- Has a baseline value of ≥20 mm on a visual analog scale (VAS) of 0-100 mm for the contralateral knee immediately before randomization after discontinuation of all painkillers for at least 7 days.

- History of secondary OA, rheumatoid arthritis, chronic inflammatory disease, or fibromyalgia.

- A history of asthma, high blood pressure, myocardial infarction, thrombotic events, stroke, heart failure, kidney dysfunction or liver disease.

- A history of gastrointestinal bleeding or peptic ulcer disease.

- Use of warfarin or other anticoagulant therapy within 30 days of randomization of the study.

- Elevated transaminases during screening.

- Use of ACE inhibitors, cyclosporine, diuretics, lithium, or methotrexate within 30 years of study randomization days.

- Concomitant use of corticosteroids or use within 30 days of randomization of the study.

- Concomitant acetylsalicylic acid therapy except for a stable low dose for cardiac prophylaxis taken at least 3 months before admission and maintained throughout the duration of the study.

- Known allergy to aspirin or a nonsteroidal anti-inflammatory drug

- Any other acute or chronic illness that could compromise the integrity of the study data or endanger the subject by participating in the study.

- Receipt of a drug as part of a research study within 30 days of screening.

- Previous participation in this study.

- Any use between the screening and baseline of a treatment or drug that may result in potentially confusing study evaluation that may confuse study evaluation (e.g. use of topical analgesics or anti-inflammatory drugs).

- Recent history of serious knee injuries or surgery.

- Known history of positive HIV