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 |
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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
Scientific
The University of Birmingham
School of Dentistry
St Chad's Queensway
Birmingham
B4 6NN
United Kingdom
Phone | +44 (0)121 237 2888 |
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j.hamburger@bham.ac.uk |
Study information
Study design | Multi-centre double-blind placebo-controlled randomised cross-over study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2002 |
Completion date | 31/12/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The University of Birmingham
Birmingham
B4 6NN
United Kingdom
B4 6NN
United Kingdom
Sponsor information
Controlled Therapeutics (Scotland) Ltd
Industry
Industry
1 Redwood Place
Peel Park Campus
East Kilbride
G74 5PB
United Kingdom
https://ror.org/03e9kb581 |
Funders
Funder type
Industry
Controlled Therapeutics (Scotland) Ltd (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
24/05/2016: No publications found, verifying study status with principal investigator.