Aceclofenac and diacerein combination treatment for arthritis

Not Applicable

• Conditions: Inflammatory osteoarthritis; Musculoskeletal Diseases; Inflammatory osteoarthritis of the knee

• Registration Number: ISRCTN74554616
• Lead Sponsor: ational Center for Rheumatic Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-22
• Last Update Posted: 27 April 2020
• Study Completion: 2020-09-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

1. Aged 18 years or older
2. Knee pain that worsens on activity and is relieved with rest
3. Early morning pain
4. Reduced medial joint space on AP view X-ray of the knee
5. Knee effusion

Exclusion Criteria

1. Psychiatric patient
2. Pregnant
3. Breastfeeding
4. No informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Improvement in pain, assessed using the Visual Analog Scale at 3, 6, 9 and 12 months after beginning treatment, along with every 3 months throughout the 1 year follow-up period<br> 2. Gastrointestinal toxicity of a tapering dose of Aceclofenac and diacerein, assessed at at 3, 6, 9 and 12 months after beginning treatment using:<br> 2.1. Patient history of nausea, vomiting, anorexia, dyspepsia, abdominal pain<br> 2.2. Liver function tests, including tests for bilirubin, aspartate transaminase (SGOT), alanine transaminase (SGPT) and alkaline phosphatase (ALP)<br> 3. Renal toxicity of a tapering dose of Aceclofenac and diacerein, assessed at at 3, 6, 9 and 12 months after beginning treatment using:<br> 3.1. Renal function tests, including tests for urea and creatinine<br> 3.2. Urine r/m/e test (complete urine examination)<br>