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 |
| Secondary identifying numbers | 2003DR4004 |
- 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
| Study design | A single-blind, placebo-controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ibuprofen-arginine 400 mg (verum) |
| Primary outcome measure | No metabolites. |
| Secondary outcome measures | Pain intensity (VAS). |
| Overall study start date | 04/03/2003 |
| Completion date | 14/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Zambon Svizzera S.A. (Switzerland)
Industry
Industry
Via Industria 13
Casella postale 200
Cadempino
CH-6814
Switzerland
| Phone | +41 (0)91 960 4118 |
|---|---|
| Ralf.Ruffmann@zambongroup.com | |
| Website | http://www.inpharzam.ch/ |
"ROR" |
https://ror.org/04zrd1t35 |
Funders
Funder type
Industry
Zambon Svizzera S.A. (Switzerland)
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 | 01/12/2006 | Yes | No |
