A comparison of bethanechol chloride and artificial saliva in the management of xerostomia in patients with cancer
| ISRCTN | ISRCTN83877765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83877765 |
| Protocol serial number | N0264120257 |
| Sponsor | Department of Health |
| Funder | United Bristol Healthcare NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 16/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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 A N T Davies
Scientific
Scientific
Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A comparison of bethanechol chloride and artificial saliva in the management of xerostomia in patients with cancer |
| Study objectives | To compare the efficacy of bethanechol chloride and Saliva Orthana in the management of xerostomia in patients with advanced cancer |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Bethanechol chloride, Saliva Orthana |
| Primary outcome measure(s) | Not provided at time of registration |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 54 |
| Key inclusion criteria | 54 patients >18 years advanced cancer, xerostomia Eastern Cooperative Oncology Group (ECOG) status 0-3 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
BS2 8HW
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 |
