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

ISRCTN	ISRCTN80708834
DOI	https://doi.org/10.1186/ISRCTN80708834
Protocol serial number	PILO-BUC-002
Sponsor	Controlled Therapeutics (Scotland) Ltd
Funder	Controlled Therapeutics (Scotland) Ltd (UK)

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

Mr John Hamburger
Scientific

The University of Birmingham
School of Dentistry
St Chad's Queensway
Birmingham
B4 6NN
United Kingdom

Phone	+44 (0)121 237 2888
Email	j.hamburger@bham.ac.uk

Primary study design	Interventional
Study design	Multi-centre double-blind placebo-controlled randomised cross-over study
Secondary study design	Randomised controlled trial
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2002

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	30
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2002

The University of Birmingham

Birmingham
B4 6NN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

24/05/2016: No publications found, verifying study status with principal investigator.