Influence of ibuprofen-arginine on serum levels of nitric oxide metabolites in patients with chronic lower back pain: a single-blind, placebo-controlled pilot trial
| ISRCTN | ISRCTN18723747 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18723747 |
| Protocol serial number | 2003DR4004 |
| Sponsor | Zambon Svizzera S.A. (Switzerland) |
| Funder | Zambon Svizzera S.A. (Switzerland) |
- Submission date
- 16/02/2006
- Registration date
- 17/02/2006
- Last edited
- 20/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Haiko Sprott
Scientific
Scientific
Department of Rheumatology
Institute of Medical Research
University Hospital of Zurich
Gloriastrasse 25
Zurich
CH-8091
Switzerland
| Phone | +41 (0)44 255 3010 |
|---|---|
| haiko.sprott@usz.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A single-blind, placebo-controlled pilot trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The present study investigates whether ibuprofen-arginine has a cyclooxygenase-independent pain modulating property besides its known anti-inflammatory effect. |
| Ethics approval(s) | Ethics approval received from the local ethics committee (Kantonale Ethics commission Zurich) on the 8th November 2002 (ref: 427). |
| Health condition(s) or problem(s) studied | Lower back pain |
| Intervention | Ibuprofen-arginine 400 mg (verum) was administered orally once. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ibuprofen-arginine 400 mg (verum) |
| Primary outcome measure(s) |
No metabolites. |
| Key secondary outcome measure(s) |
Pain intensity (VAS). |
| Completion date | 14/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | Non-specific chronic lower back pain (Visual Analogue Scale [VAS] greater than or equal to 60). |
| Key exclusion criteria | Specific lower back pain. |
| Date of first enrolment | 04/03/2003 |
| Date of final enrolment | 14/10/2003 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Department of Rheumatology
Zurich
CH-8091
Switzerland
CH-8091
Switzerland
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 | 01/12/2006 | Yes | No |
