Trial Outcomes & Findings for Duration of Effect of Biotene Spray in Patients With Dry Mouth (NCT NCT03663231)

Last Updated: 2021-01-20

Results Overview

Participant will receive a dose of Biotene or placebo (water) and will be asked if their mouth is dry up to 2 hrs. The time at which their mouth becomes dry again will be the duration of action.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

baseline up to 2 hours

Results posted on

2021-01-20

Participant Flow

37 subjects were enrolled. 8 subjects failed screening. 16 were randomized to either the Biotene then placebo arm and 13 were randomized to the water then Biotene arm.

Participant milestones

Participant milestones
Measure	Biotene Then Placebo People who present with dry mouth and will receive a single dose of Biotene. Biotene: Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL.	Placebo Then Biotene People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
First Intervention STARTED	16	13
First Intervention COMPLETED	14	12
First Intervention NOT COMPLETED	2	1
Washout STARTED	14	12
Washout COMPLETED	14	12
Washout NOT COMPLETED	0	0
Second Intervention STARTED	14	12
Second Intervention COMPLETED	14	12
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant did not have data collected for age in the Biotene then Placebo arm.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biotene Then Placebo n=16 Participants People who present with dry mouth and will receive a single dose of Biotene. Biotene: Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL.	Placebo Then Biotene n=13 Participants People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants • One participant did not have data collected for age in the Biotene then Placebo arm.	0 Participants n=13 Participants • One participant did not have data collected for age in the Biotene then Placebo arm.	0 Participants n=28 Participants • One participant did not have data collected for age in the Biotene then Placebo arm.
Age, Categorical Between 18 and 65 years	9 Participants n=15 Participants • One participant did not have data collected for age in the Biotene then Placebo arm.	10 Participants n=13 Participants • One participant did not have data collected for age in the Biotene then Placebo arm.	19 Participants n=28 Participants • One participant did not have data collected for age in the Biotene then Placebo arm.
Age, Categorical >=65 years	6 Participants n=15 Participants • One participant did not have data collected for age in the Biotene then Placebo arm.	3 Participants n=13 Participants • One participant did not have data collected for age in the Biotene then Placebo arm.	9 Participants n=28 Participants • One participant did not have data collected for age in the Biotene then Placebo arm.
Sex: Female, Male Female	12 Participants n=16 Participants	9 Participants n=13 Participants	21 Participants n=29 Participants
Sex: Female, Male Male	4 Participants n=16 Participants	4 Participants n=13 Participants	8 Participants n=29 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=16 Participants	0 Participants n=13 Participants	1 Participants n=29 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=16 Participants	13 Participants n=13 Participants	28 Participants n=29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=29 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=29 Participants
Race (NIH/OMB) Asian	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=29 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=29 Participants
Race (NIH/OMB) Black or African American	4 Participants n=16 Participants	2 Participants n=13 Participants	6 Participants n=29 Participants
Race (NIH/OMB) White	12 Participants n=16 Participants	11 Participants n=13 Participants	23 Participants n=29 Participants
Race (NIH/OMB) More than one race	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=29 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=29 Participants
Region of Enrollment United States	16 participants n=16 Participants	13 participants n=13 Participants	29 participants n=29 Participants

PRIMARY outcome

Timeframe: baseline up to 2 hours

Participant will receive a dose of Biotene or placebo (water) and will be asked if their mouth is dry up to 2 hrs. The time at which their mouth becomes dry again will be the duration of action.