Contact information
Type
Scientific
Primary contact
Mr John Hamburger
ORCID ID
Contact details
The University of Birmingham
School of Dentistry
St Chad's Queensway
Birmingham
B4 6NN
United Kingdom
+44 (0)121 237 2888
j.hamburger@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PILO-BUC-002
Study information
Scientific title
Assessment of controlled release buccal inserts containing pilocarpine hydrochloride: a multi-centre, double-blind, placebo-controlled, randomised, cross-over study in patients diagnosed with Sjögren's Syndrome
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Multi-centre double-blind placebo-controlled randomised cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Sjögren's Syndrome
Intervention
This trial is a 'cross-over' study with four treatment cycles. For each treatment cycle, patients will be provided with 12 buccal inserts, containing one of the following: 2.5, 5 or 10 mg pilocarpine or placebo. A treatment cycle is four days long, however, there will be a three day washout period between each new dose. The buccal insert is a hydrogel polymer with pilocarpine dispersed throughout the matrix. Each buccal insert should be inserted high in the upper buccal sulcus between the buccal mucosa and gingivae towards the back of the mouth and remain in situ for at least three hours. One buccal insert should be inserted three times daily in the period between meals.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Approximately 30 patients with primary or secondary Sjögren's Syndrome, as diagnosed by the modified European Diagnostic Classification, will be enrolled into the study, to accrue 25 evaluable patients
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
31/12/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Birmingham
Birmingham
B4 6NN
United Kingdom
Funders
Funder type
Industry
Funder name
Controlled Therapeutics (Scotland) Ltd (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