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

NCT01369589 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-04-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Parion Sciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369589 on ClinicalTrials.gov