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 |
| Protocol serial number | N0084096586 |
| Sponsor | Department of Health |
| Funder | The North and South Bank Research and Development Consortium (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind cross-over trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Proglumide |
| Primary outcome measure(s) |
Primary end-point: less fearfulness (as measured by anxiety and activity avoidance) in the proglumide phase of the crossover trial. |
| Key secondary outcome measure(s) |
Secondary end-points: reduced pain scores during the proglumide phase, increased fearfulness during the ascorbic acid phase in nocebo responders. |
| Completion date | 01/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
