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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN80708834
Enrollment
30
Registered
2002-09-23
Start date
2002-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjögren's Syndrome Musculoskeletal Diseases Systemic involvement of connective tissue

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

Sponsors

Controlled Therapeutics (Scotland) Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration—

Secondary

MeasureTime frame
Not provided at time of registration—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026