Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/02/2006
Date assigned
17/02/2006
Last edited
20/12/2007
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 Haiko Sprott

ORCID ID

Contact details

Department of Rheumatology
Institute of Medical Research
University Hospital of Zurich
Gloriastrasse 25
Zurich
CH-8091
Switzerland
+41 (0)44 255 3010
haiko.sprott@usz.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2003DR4004

Study information

Scientific title

Acronym

Study hypothesis

The present study investigates whether ibuprofen-arginine has a cyclooxygenase-independent pain modulating property besides its known anti-inflammatory effect.

Ethics approval

Ethics approval received from the local ethics committee (Kantonale Ethics commission Zurich) on the 8th November 2002 (ref: 427).

Study design

A single-blind, placebo-controlled pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Lower back pain

Intervention

Ibuprofen-arginine 400 mg (verum) was administered orally once.

Intervention type

Drug

Phase

Not Specified

Drug names

Ibuprofen-arginine 400 mg (verum)

Primary outcome measures

No metabolites.

Secondary outcome measures

Pain intensity (VAS).

Overall trial start date

04/03/2003

Overall trial end date

14/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Non-specific chronic lower back pain (Visual Analogue Scale [VAS] greater than or equal to 60).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Specific lower back pain.

Recruitment start date

04/03/2003

Recruitment end date

14/10/2003

Locations

Countries of recruitment

Switzerland

Trial participating centre

Department of Rheumatology
Zurich
CH-8091
Switzerland

Sponsor information

Organisation

Zambon Svizzera S.A. (Switzerland)

Sponsor details

Via Industria 13
Casella postale 200
Cadempino
CH-6814
Switzerland
+41 (0)91 960 4118
Ralf.Ruffmann@zambongroup.com

Sponsor type

Industry

Website

http://www.inpharzam.ch/

Funders

Funder type

Industry

Funder name

Zambon Svizzera S.A. (Switzerland)

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17013995

Publication citations

  1. Results

    Sprott H, Gay RE, Michel BA, Gay S, Influence of ibuprofen-arginine on serum levels of nitric oxide metabolites in patients with chronic low back pain--a single-blind, placebo controlled pilot trial (ISRCTN18723747)., J. Rheumatol., 2006, 33, 12, 2515-2518.

Additional files

Editorial Notes