Randomised double-blind cross-over trial of proglumide in patients with chronic pain and/or fatigue
| ISRCTN | ISRCTN47564212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47564212 |
| Secondary identifying numbers | N0084096586 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 03/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Derek R Haines
Scientific
Scientific
Anaesthetic Department
Hull and East Yorkshire Hospitals NHS Trust
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Study information
| Study design | Randomised double-blind cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised double-blind cross-over trial of proglumide in patients with chronic pain and/or fatigue |
| Study objectives | Does proglumide offer benefit to fearful chronic pain patients, and/or patients with the chronic fatigue syndrome? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | Randomised double blind cross-over design. Baseline week of symptom diaries and questionnaires. Four weeks on either proglumide or inactive preparation, then mid study questionnaires. Four weeks on crossover preparation. Final questions. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Proglumide |
| Primary outcome measure | Primary end-point: less fearfulness (as measured by anxiety and activity avoidance) in the proglumide phase of the crossover trial. |
| Secondary outcome measures | Secondary end-points: reduced pain scores during the proglumide phase, increased fearfulness during the ascorbic acid phase in nocebo responders. |
| Overall study start date | 01/02/2000 |
| Completion date | 01/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key inclusion criteria | 40 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/02/2000 |
| Date of final enrolment | 01/09/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Other
The North and South Bank Research and Development Consortium (UK)
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 |
