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 |
| Protocol serial number | HS#2000-1046 |
| Sponsor | University of California, Irvine, Medical Center (UCIMC) (USA) |
| Funder | University of California, Irvine, Medical Center (UCIMC) (USA) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | S-Adenosyl methionine (SAMe), celecoxib |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
