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A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study

NCT02049112 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2014-01-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal® \& Biotene®) in patients with xerostomia due to chronic hyposalivation.

Conditions

Interventions

DEVICE

Salivary equivalent

14-day treatment with salivary equivalent sticks

DEVICE

Aequasyal

14-day treatment with Aequasyal oral spray

DEVICE

Biotene

14-day treatment with Biotene oral spray

Sponsors & Collaborators

  • Unither Pharmaceuticals, France

    lead INDUSTRY

Principal Investigators

  • Michel SALOM, Medical · Leopold Bellan Fundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT02049112 on ClinicalTrials.gov