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
Secondary identifying numbers PILO-BUC-002
Submission date
23/09/2002
Registration date
23/09/2002
Last edited
24/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
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

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

Study information

Study designMulti-centre double-blind placebo-controlled randomised cross-over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleAssessment 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 objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSjögren's Syndrome
InterventionThis 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2002
Completion date31/12/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Key inclusion criteriaApproximately 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2002
Date of final enrolment31/12/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The University of Birmingham
Birmingham
B4 6NN
United Kingdom

Sponsor information

Controlled Therapeutics (Scotland) Ltd
Industry

1 Redwood Place
Peel Park Campus
East Kilbride
G74 5PB
United Kingdom

ROR logo "ROR" https://ror.org/03e9kb581

Funders

Funder type

Industry

Controlled Therapeutics (Scotland) Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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