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Spots Global Cancer Trial Database for A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study

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We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: Phase 4 Study Evaluating Efficacy, Safety and Acceptability of Treatment With a New Salivary Equivalent Compared to Two Moisturizing Mouth Sprays on the Improvement of Dry Mouth Symptoms and Oral Comfort in Patients With Xerostomia.

Study ID: NCT02049112

Study Description

Brief 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.

Detailed Description: National, multicentre, randomised, active controlled, crossover, open-label study using a 3-latin-square design. 200 evaluable patients have been recruited

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Leopold Bellan Private Hospital, Magnanville, , France

Contact Details

Name: Michel SALOM, Medical

Affiliation: Leopold Bellan Fundation

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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