NCT04289051

Clinical Evaluation of Oral Rinse for Xerostomia

Completed NA Results posted Last updated 24 February 2022

What this trial tests

NA trial testing HYDRAL Oral Rinse in Xerostomia in 39 participants. Completed in 4 February 2021.

Timeline

19 August 2020

Primary endpoint
4 February 2021

4 February 2021

Quick facts

Lead sponsor	Sunstar Americas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	39
Start date	19 August 2020
Primary completion	4 February 2021
Estimated completion	4 February 2021
Sites	1 location across United States

Drugs / interventions tested

• HYDRAL Oral Rinse
• BIOTENE® Oral Rinse
• Placebo Oral Rinse

Conditions studied

• Xerostomia — all drugs for Xerostomia →

Sponsor

Sunstar Americas — full company profile →

Who can join

Adults 18 to 80, any sex, with Xerostomia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline Primary · Baseline, 14 days

100 mm visual analog scale for subjective scoring the level of dry mouth (0 mm: not dry at all, 100 mm: very dry). Change in mm was calculated by subtracting the measurement at 14 days from the measurement at baseline. Higher values of the changes from baseline represent a better outcome.

Group	Value	95% CI
HYDRAL Oral Rinse	10.1	± 2.5
Placebo Oral Rinse	11.6	± 3.9
BIOTENE® Oral Rinse	13.0	± 3.2

Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline Primary · Baseline, 14 days

Questionnaire to assess xerostomia symptoms. Subjects were asked the degree (grade 0: no problems to grade 3: the worst possible problem) of hoarse voice, oral dryness, oral pain, swallowing, and taste loss from which they were suffering in the xerostomia questionnaire. The symptoms scores were summed to calculate a total score per each subject (minimum total score: 0, maximum total score: 15). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -15, maximum change: 15).

Group	Value	95% CI
HYDRAL Oral Rinse	1.0	± 2.8
Placebo Oral Rinse	0.4	± 1.7
BIOTENE® Oral Rinse	0.5	± 1.5

Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline Secondary · Baseline, 14 days

Assessment of oral functions by a dental professional. Eight categories were included in the assessment guide: voice, lips, mucous membranes, tongue, gums, teeth, saliva, and swallowing. Each category was described and rated from healthy (score 1) to severe (score 3). Scores for the categories were summed to calculate a total score per each subject (minimum total score: 8, maximum total score: 24). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -16, maximum change: 16

Group	Value	95% CI
HYDRAL Oral Rinse	2.0	± 1.3
Placebo Oral Rinse	0	± 1.7
BIOTENE® Oral Rinse	1.2	± 1.5

Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline Secondary · Baseline, 14 days

Unstimulated whole saliva was collected over a 5-minute time period and the volume was measured. Change in mL per minute was calculated by subtracting the measurement at baseline from the measurement at 14 days.

Group	Value	95% CI
HYDRAL Oral Rinse	0.08	± 0.11
Placebo Oral Rinse	0.00	± 0.08
BIOTENE® Oral Rinse	0.05	± 0.12

Adverse events — posted to ClinicalTrials.gov

Time frame: 14 days. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HYDRAL Oral Rinse

Serious: 0/37 (0%)

Deaths: 0/37

Placebo Oral Rinse

Serious: 0/37 (0%)

Deaths: 0/37

BIOTENE® Oral Rinse

Serious: 0/37 (0%)

Deaths: 0/37

Other adverse events (3 terms — click to expand)

Reaction	System	HYDRAL Oral Rinse	Placebo Oral Rinse	BIOTENE® Oral Rinse
Oral mucosal irritation	Gastrointestinal disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—	—

Data from ClinicalTrials.gov NCT04289051 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.