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ISRCTN
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ISRCTN80708834
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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PILO-BUC-002
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Multi-centre double-blind placebo-controlled randomised cross-over study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Sjögren's Syndrome
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2002
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Anticipated end date
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31/12/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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30
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Controlled Therapeutics (Scotland) Ltd (UK)
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Trial website
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Publications
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Contact name
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Mr
John
Hamburger
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Address
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The University of Birmingham
School of Dentistry
St Chad's Queensway
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City/town
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Birmingham
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Zip/Postcode
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B4 6NN
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Country
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United Kingdom
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Tel
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+44 (0)121 237 2888
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Fax
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+44 (0)121 625 8815
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Email
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j.hamburger@bham.ac.uk
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Sponsor
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Controlled Therapeutics (Scotland) Ltd
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Address
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1 Redwood Place
Peel Park Campus
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City/town
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East Kilbride
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Zip/Postcode
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G74 5PB
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Country
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United Kingdom
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Tel
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+44 (0)1355 239166
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Fax
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+44 (0)1355 263661
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Email
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Date applied
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23/09/2002
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Last edited
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28/01/2010
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Date ISRCTN assigned
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23/09/2002
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