Oral cetylated fatty acid for the improvement of function, quality of life, and pain in patients with moderate to severe knee osteoarthritis
| ISRCTN | ISRCTN82731853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82731853 |
| Secondary identifying numbers | IX100 |
- Submission date
- 14/07/2007
- Registration date
- 08/08/2007
- Last edited
- 29/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jay Udani
Scientific
Scientific
18250 Roscoe Boulevard
Suite 240
Northridge
91325
United States of America
Study information
| Study design | 74-day randomised, double-blind, placebo-controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Oral cetylated fatty acid for the improvement of function, quality of life, and pain in patients with moderate to severe knee osteoarthritis |
| Study objectives | To determine if oral cetylated fatty acid (Celadrin®) improves musculoskeletal performance, improves quality of life, and reduces pain and in patients with moderate to severe osteoarthritis of the knee. |
| Ethics approval(s) | Ethics approval received from the Copernicus Group Institutional Review Board (CGIRB) ont he 23rd January 2006 (ref: Tracking # MED4-05-237). |
| Health condition(s) or problem(s) studied | Osteoarthritis of the knee |
| Intervention | Celadrin® (oral cetylated fatty acid) 1720 mg per day or placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cetylated fatty acid (Celadrin®) |
| Primary outcome measure | Six-minute timed walk, assessed at baseline, 2, 4 and 8 weeks. |
| Secondary outcome measures | The following were assessed at baseline, 2, 4 and 8 weeks: 1. Pain Visual Analogue Scale (VAS) 2. Timed up and go test 3. Unilateral anterior reach 4. Western Ontario and McMasters Universities Osteoarthritic (WOMAC) index 5. Lequesne Algofunctional Index (LAI) 6. ROM |
| Overall study start date | 01/01/2006 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 93 |
| Key inclusion criteria | 1. Diagnosis of moderate to severe osteoarthritis of the knee by American College of Rheumatology (ACR) clinical criteria (95% sensitive and 69% specific) 2. Pain in the knee 3. At least three of the following: 3.1. Age greater than or equal to 40 (note - original ACR Criteria call for age greater than 50) 3.2. Morning stiffness lasting 30 minutes or less 3.3. Demonstration of crepitus during knee Range Of Motion (ROM) 3.4. Bony tenderness 3.5. Bony enlargement 3.6. No palpable warmth 4. Presence of knee pain greater than six months 5. Presence of knee pain for at least 10 days in the previous month 6. Subjects agree to stop all pain medications 7. Baby aspirin (81 mg) is allowed 8. Subject agrees to all study visits 9. Females of child bearing potential must agree to use appropriate birth control methods during the active study 10. Must agree not to initiate any new exercise or diet program during the study 11. Must agree not to change their current diet or exercise program |
| Key exclusion criteria | 1. Rheumatoid arthritis or other autoimmune arthritis 2. Receipt of glucocorticoid injection or hyaluronic acid injection in affected knee within the last three months 3. Use of cetylated fatty acid within the 45 days prior to screening 4. Serious active medical conditions 5. Corticosteroids or other immunosuppressants 6. Current use of insulin or use of insulin in the past three months 7. Non-compliance during the run-in phase of the study 8. Cannot perform all of the required functional assessments 9. Subjects unable to understand or follow the study protocol 10. Subjects with known sensitivities to the ingredients in the product 11. Subjects with any cancer in the last five years (except non-melanoma skin cancer) 12. Subjects on anticoagulation therapy 13. Subjects with brain and/or spinal cord injury 14. Bed or wheelchair bound |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- United States of America
Study participating centre
18250 Roscoe Boulevard
Northridge
91325
United States of America
91325
United States of America
Sponsor information
Imagenetix Inc. (USA)
Industry
Industry
16935 W. Bernardo Drive
San Diego
92127
United States of America
| Website | http://www.imagenetix.net/ |
|---|
Funders
Funder type
Industry
Imagenetix Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Funder report results | Results (non peer reviewed) on funder website | 20/01/2011 | 29/10/2021 | No | No |
Editorial Notes
29/10/2021: The following changes have been made:
1. Online report (not peer-reviewed) added.
2. The total final enrolment number has been added from the reference.
