NCT01369589

An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness

An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Parion Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical study is to determine the impact of P-552 oral rinse on salivary volume after administration of a single dose of P-552and versus vehicle rinse. Changes in oral mucosal wetness will be assessed via collection of salivary output and via measurement of oral wetness using the Periotron 8000 instrument.

Conditions

• Xerostomia
• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	P-552	P-552 will be administered as 10 mL mouth rinse to be swished in the mouth fro 30 seconds and then completely expectorated.
DRUG	Placebo	Placebo will be administered as 10 mL mouth rinse to be swished in the mouth for 30 seconds and then completely expectorated.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-06-09
• Last updated: 2019-04-23

Locations

1 site across 1 country: United States