Aceclofenac and diacerein combination treatment for arthritis
| ISRCTN | ISRCTN74554616 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74554616 |
| Secondary identifying numbers | 200/2017 Nepal Health Research Council (NHRC) |
- Submission date
- 07/08/2018
- Registration date
- 22/08/2018
- Last edited
- 03/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Osteoarthritis is a common progressive disease affecting weight-bearing joints. Though traditionally deemed a degenerative disease, it is now believed that inflammatory pathways also play an important relationship in this disease. Aceclofenac and diacerein are both anti-inflammatory drugs used to treat osteoarthritis; however, they are only used individually, rather than in combination. This study aims to look at the effects of combining Aceclofenac and diacerein.
Who can participate?
Adults with inflammatory osteoarthritis of the knee
What does the study involve?
Patients will be randomised into the study and control groups. Patients in the intervention group will receive treatment with Aceclofenac and diacerein for a year, whereas patients in the control group will receive physiotherapy treatment. For both groups, patients will be assessed for pain, stiffness, physical function and general health, along with completing X-rays and liver and kidney function tests.
What are the possible benefits and risks of participating?
The possible benefit of participating is that the combination of Aceclofenac and diacerein may be more effective than using either drug alone. There are no known risks to participants, and they will be monitored for any side effects through routine physical and laboratory examinations every 3 months.
Where is the study run from?
National Center for Rheumatic Diseases, Kathmandu, Nepal
When is the study starting and how long is it expected to run for?
June 2017 to October 2018
Who is funding the study?
National Center for Rheumatic Disease (Nepal)
Who is the main contact?
Dr. Binit Vaidya
drbvaidya@gmail.com
Contact information
Public
Chairman and Head of Rheumatology
National Center for Rheumatic Diseases
Ratopul, Gaushala
Kathmandu-9
44600
Nepal
 ORCID ID |
0000-0002-4840-8924 |
|---|
Public
National Center for Rheumatic Diseases
Ratopul, Gaushala
Kathmandu-9
44600
Nepal
Public
National Center for Rheumatic Diseases
Ratopul, Gaushala
Kathmandu-9
44600
Nepal
Public
National Center for Rheumatic Diseases
Ratopul, Gaushala
Kathmandu-9
44600
Nepal
Public
National Center for Rheumatic Diseases
Ratopul, Gaushala
Kathmandu-9
44600
Nepal
Public
National Center for Rheumatic Diseases
Ratopul
Gaushala
Kathmandu-9
44600
Nepal
Study information
| Study design | Observational prospective open-label randomised case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Efficacy and tolerance of aceclofenac and diacerein combination for inflammatory osteoarthritis |
| Study hypothesis | Aceclofenac and diacerein combination used in inflammatory osteoarthritis is more efficacious and safe compared to aceclofenac monotherapy |
| Ethics approval(s) | Nepal Health Research Council (NHRC), 14/03/2018, 200/2017 |
| Condition | Inflammatory osteoarthritis |
| Intervention | Patient will be allocated into 2 groups - the intervention group and the control group. Patients in the intervention group will be treated with Aceclofenac and diacerein. Aceclofenac will be given at the starting dose of 100 mg twice daily for the first 10 days. The dose will then be tapered to 100 mg every day for next 10 days. The dose will then be further reduced to 50 mg per day for next 10 days and a final dose of 50 mg on alternate days will be given for 10 more days. Diacerein will be given at the dose of 50 mg twice daily for the initial 3 months after which the dose will be reduced to 50 mg per day for the next 9 months, Patients in the control group will be managed with physiotherapy alone. At the onset of treatment, the Visual Analogue Score (VAS), Health Assessment Questionnaire (HAQ) score, Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) score and X-ray findings of each patient will be recorded. Follow up will be done regularly at 3 month intervals, where clinical improvement will be recorded with VAS Score, HAQ score, and WOMAC score. X-rays will be repeated at the end of 1 year. The side effects will also be monitored by careful questioning and physical examination, along with renal and liver function tests and care. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Aceclofenac Diacerein |
| Primary outcome measure | 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 2. Gastrointestinal toxicity of a tapering dose of Aceclofenac and diacerein, assessed at at 3, 6, 9 and 12 months after beginning treatment using: 2.1. Patient history of nausea, vomiting, anorexia, dyspepsia, abdominal pain 2.2. Liver function tests, including tests for bilirubin, aspartate transaminase (SGOT), alanine transaminase (SGPT) and alkaline phosphatase (ALP) 3. Renal toxicity of a tapering dose of Aceclofenac and diacerein, assessed at at 3, 6, 9 and 12 months after beginning treatment using: 3.1. Renal function tests, including tests for urea and creatinine 3.2. Urine r/m/e test (complete urine examination) |
| Secondary outcome measures | 1. Long-term effects of diacerein alone over 1 year, assessed by: 1.1. Visual Analogue Score (VAS) for pain, at 3, 6, 9 and 12 months after beginning treatment, along with every 3 months throughout the 1 year follow-up period 1.2. Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) score at 3, 6, 9 and 12 months after beginning treatment, along with every 3 months throughout the 1 year follow-up period 1.3. Kellgren-Lawrence Classification of Osteoarthritis (KL grading), determined from an X-ray taken 12 months after beginning treatment and at the end of the 1 year follow-up period 2. Change and maintenance of functional status of patients, assessed using the Western Ontario & McMaster Universities Osteoarthritis (WOMAC) score at 3, 6, 9 and 12 months after beginning treatment 3. Change in physical disability, assessed using the Health Assessment Questionnaire (HAQ) at 3, 6, 9 and 12 months after beginning treatment 4. Change in radiographic findings over 1 year, assessed using the Kellgren-Lawrence Classification of Osteoarthritis (KL grading), determined from an X-ray taken 12 months after beginning treatment |
| Overall study start date | 01/06/2017 |
| Overall study end date | 15/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 384 |
| Participant 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 |
| Participant exclusion criteria | 1. Psychiatric patient 2. Pregnant 3. Breastfeeding 4. No informed consent |
| Recruitment start date | 01/09/2019 |
| Recruitment end date | 15/04/2020 |
Locations
Countries of recruitment
- Nepal
Study participating centre
Kathmandu
44600
Nepal
Sponsor information
Hospital/treatment centre
Ratopul, Gaushala
Kathmandu-9
44600
Nepal
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 30/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish clinicodemographic data, safety-efficacy results, and future ad-hoc results. |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Dr Binit Vaidya (drbvaidya@gmail.com). |
Editorial Notes
03/04/2020: The following changes have been made:
1. The overall trial end date has been changed from 30/10/2018 to 15/09/2020.
2. The intention to publish date has been changed from 30/10/2019 to 30/12/2020.
3. The recruitment start date has been changed from 15/07/2017 to 01/09/2019.
4. The recruitment end date has been changed from 15/10/2017 to 15/04/2020.
