Condition category
Musculoskeletal Diseases
Date applied
23/09/2002
Date assigned
23/09/2002
Last edited
24/05/2016
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

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

Sponsor information

Organisation

Controlled Therapeutics (Scotland) Ltd

Sponsor details

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

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes

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