Condition category
Musculoskeletal Diseases
Date applied
14/07/2007
Date assigned
08/08/2007
Last edited
09/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jay Udani

ORCID ID

Contact details

18250 Roscoe Boulevard
Suite 240
Northridge
91325
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IX100

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the Copernicus Group Institutional Review Board (CGIRB) ont he 23rd January 2006 (ref: Tracking # MED4-05-237).

Study design

74-day randomised, double-blind, placebo-controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritis of the knee

Intervention

Celadrin® (oral cetylated fatty acid) 1720 mg per day or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Cetylated fatty acid (Celadrin®)

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United States of America

Trial participating centre

18250 Roscoe Boulevard
Northridge
91325
United States of America

Sponsor information

Organisation

Imagenetix Inc. (USA)

Sponsor details

16935 W. Bernardo Drive
San Diego
92127
United States of America

Sponsor type

Industry

Website

http://www.imagenetix.net/

Funders

Funder type

Industry

Funder name

Imagenetix Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes