Amtolmetin Gaucil in Knee Osteoarthritis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is conducted to study the efficacy and safety of Niselat in patients with osteoarthritis.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited

Criteria

Inclusion Criteria:

1. Informed consent form for participation in the study;

2. KOA (based on ACR, 1987)

3. Age between 30-60 years old

4. Previous regular administration of NSAIDs for at least 4 weeks (at maximum therapeutic dose)

5. Dyspeptic symptoms (according to SODA questionnaire)

6. Pain intensity in the investigated knee joint ≥ 40 mm according to VAS

7. Subjects with systolic blood pressure ≤ 140 mm Hg and diastolic BP ≤90 mmHg against stable antihypertensive therapy.

Exclusion Criteria:

1. Contraindications to amtolmetin guacil (according to patient information leaflet)

2. Subjects with SBP ≥140 mm Hg and DBP ≥90 mm Hg

3. Signs of renal or hepatic failure;

4. Pregnancy, lactation or planning for pregnancy.

5. One of the following changes in laboratory values at screening HGB, WBC, ESR, ALT, AST.