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A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome

NCT00852839 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-09-18

No results posted yet for this study

Summary

This clinical study is to determine whether daily administration of a formulation of 552-02 improves the dry mouth condition in subjects with primary Sjögren's syndrome.

Conditions

  • Dry Mouth Associated With Sjogren's Syndrome
  • Xerostomia

Interventions

DRUG

Placebo

Placebo to match oromucosal formulation of 552-02

DRUG

552-02

The oromucosal formulation of 552-02 contains 552-02 (25 μg/mL), surfactant, flavoring agents, a humectant, and preservatives.

Sponsors & Collaborators

  • Parion Sciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-10-31
Completion
2009-11-30

Countries

  • United States

Study Locations

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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 NCT00852839 on ClinicalTrials.gov