S-Adenosyl methionine (SAMe) versus celecoxib for the treatment of osteoarthritis symptoms: a double-blind cross-over trial
| ISRCTN | ISRCTN36233495 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36233495 |
| Secondary identifying numbers | HS#2000-1046 |
- Submission date
- 12/02/2004
- Registration date
- 13/02/2004
- Last edited
- 16/08/2011
- 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 Wadie Najm
Scientific
Scientific
101 The City Drive
Bldg 200 #512, Rt81
Orange
92868
United States of America
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Arthritis |
| Intervention | Participants were randomised to receive SAMe or Celebrex over two months. Pain, quality of life and musculoskeletal measures were assessed before, during and after the study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | S-Adenosyl methionine (SAMe), celecoxib |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2000 |
| Completion date | 01/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 61 |
| Key inclusion criteria | Volunteers |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 01/09/2002 |
Locations
Countries of recruitment
- United States of America
Study participating centre
101 The City Drive
Orange
92868
United States of America
92868
United States of America
Sponsor information
University of California, Irvine, Medical Center (UCIMC) (USA)
Hospital/treatment centre
Hospital/treatment centre
300 University Tower
Irvine
92697
United States of America
"ROR" |
https://ror.org/00cm8nm15 |
|---|
Funders
Funder type
Hospital/treatment centre
University of California, Irvine, Medical Center (UCIMC) (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 26/02/2004 | Yes | No |
