Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
09/09/2016
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 Gary Cook

ORCID ID

Contact details

Nuclear Medicine
The Royal Marsden NHS Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
+44 020 8661 3921
gcook@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0258113080

Study information

Scientific title

Salivary gland protection from iodine-131 therapy; evaluation of salivary stimulating tablets efficacy using 131 iodine dosimetry and salivary gland scintigraphy

Acronym

Study hypothesis

To compare iodine-131 salivary gland dosimetry in patients taking SST and those under a standard treatment protocol (sucking sweets).

Ethics approval

Not provided at time of registration

Study design

Non blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Digestive System: Salivation

Intervention

Randomised test intervention versus standardised intervention, non-blinded (Phase 3).

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

If this study shows that SST has efficacy in salivary radioprotection then this could then be incorporated into standard radioiodine treatment protocols.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2002

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2002

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nuclear Medicine
Sutton, Surrey
SM2 5PT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

The Royal Marsden 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

09/09/2016: No publications found in PubMed, verifying study status with principal investigator.