Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
03/11/2015
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 Derek R Haines

ORCID ID

Contact details

Anaesthetic Department
Hull and East Yorkshire Hospitals NHS Trust
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084096586

Study information

Scientific title

Randomised double-blind cross-over trial of proglumide in patients with chronic pain and/or fatigue

Acronym

Study hypothesis

Does proglumide offer benefit to fearful chronic pain patients, and/or patients with the chronic fatigue syndrome?

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind cross-over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Proglumide

Primary outcome measures

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 trial start date

01/02/2000

Overall trial end date

01/09/2002

Reason abandoned

Eligibility

Participant inclusion criteria

40

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/02/2000

Recruitment end date

01/09/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Other

Funder name

The North and South Bank Research and Development Consortium (UK)

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

Publication citations

Additional files

Editorial Notes