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HYDRAL Oral Rinse for Catheter Site Dryness

N/A
Waitlist Available
Research Sponsored by Sunstar Americas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 14 days

Summary

Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. The objectives of the clinical study is to evaluate the effectiveness of the oral rinse comparing to the placebo product and the control product in the market. This is a randomized double-blind placebo controlled crossover study with 39 patients receiving treatment. Patients will be randomly allocated to three treatment groups. Patients will use the assigned oral rinse four times a day for two weeks. Dry mouth symptoms and other endpoints will be assessed subjectively and objectively at baseline and Day 14. Patients will be assigned to another treatment after one week wash-out period.

Eligible Conditions
  • Catheter Site Dryness
  • Dry Mouth

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline
Xerostomia
Secondary study objectives
Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline
Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: HYDRAL Oral RinseExperimental Treatment3 Interventions
Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.
Group II: BIOTENE® Oral RinseActive Control3 Interventions
Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.
Group III: Placebo Oral RinsePlacebo Group3 Interventions
Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HYDRAL Oral Rinse
2020
N/A
~40
BIOTENE® Oral Rinse
2020
N/A
~40
Placebo Oral Rinse
2015
N/A
~520

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Who is running the clinical trial?

Sunstar AmericasLead Sponsor
10 Previous Clinical Trials
885 Total Patients Enrolled
~8 spots leftby Nov 2025
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