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
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