Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
16/12/2014
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 A N T Davies

ORCID ID

Contact details

Level 1
The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264120257

Study information

Scientific title

A comparison of bethanechol chloride and artificial saliva in the management of xerostomia in patients with cancer

Acronym

Study hypothesis

To compare the efficacy of bethanechol chloride and Saliva Orthana in the management of xerostomia in patients with advanced cancer

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Digestive System: Xerostomia

Intervention

Participants will be randomised to one week's treatment with:
1. Bethanechol chloride or
2. Saliva Orthana

Intervention type

Drug

Phase

Not Specified

Drug names

Bethanechol chloride, Saliva Orthana

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2002

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

54 patients >18 years advanced cancer, xerostomia Eastern Cooperative Oncology Group (ECOG) status 0-3

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

54

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2002

Recruitment end date

30/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Infirmary
Bristol
BS2 8HW
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

Hospital/treatment centre

Funder name

United Bristol Healthcare NHS Trust (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