Phase 3, duble-blind, randomized, parallel study to evaluate the efficacy of glucosamine sulfate and meloxicam administered in combination or glucosamine sulfate and meloxicam administered separately to subjects with mild to moderate osteoarthiritis of the knee or hip

Completed

• Conditions: Mild to moderate osteoarthrits; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12608000568314
• Lead Sponsor: Zodiac Produtos Farmacêuticos S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Patients between 40 and 60 years old
- Knee or hip osteoarthritis radiologic and clinical diagnosis
- lesion intensity should be mild to moderate (level 2 or 3 in Kellgren-Lawrence classification)
- normal laboratory exams
- informed consent

Exclusion Criteria

- not used corticosteroids during the last 30 days
- not used non steroidal antinflamatory during the last 7 days
- immunomodulators previous use
- intrarticular medication during the last 6 months
- previous surgery in knee or hip and prosthesis use
- pregnant
- organic disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical activity evaluation measured by WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire.[Evaluation will be measured in baseline - visit 2 (randomization day), visit 3 (week 2), visit 4 (week 4), visit 5 (week 6), visit 6 (week 8), visit 7 (week 10), visit 8 (week 12 - end of treatment period)]