| Source of record | UK Trials |
| ISRCTN | ISRCTN80708834 |
| Date ISRCTN assigned | 23/09/2002 |
| Local reference number(s) | PILO-BUC-002 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Sjögren's Syndrome |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 01/01/2002 |
| Anticipated end date | 31/12/2002 |
| Status of trial | Completed |
| Target number of participants | 30 |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Controlled Therapeutics (Scotland) Ltd |
| Sponsor name | Controlled Therapeutics (Scotland) Ltd |
| Sponsor details | 1 Redwood Place
Peel Park Campus
East Kilbride
United Kingdom
G74 5PB |
| Sponsor telephone | +44 (0)1355 239166 |
| Sponsor fax | +44 (0)1355 263661 |
| Contact name | Mr John Hamburger |
| Contact details | The University of Birmingham
School of Dentistry
St Chad's Queensway
Birmingham
United Kingdom
B4 6NN |
| Contact telephone | +44 (0)121 237 2888 |
| Contact fax | +44 (0)121 625 8815 |
| Contact email | j.hamburger@bham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN80708834 |
| Date last extracted from ISRCTN register | 17/04/2008 |
