An interventional study of HYDRAL Oral Rinse and BIOTENE® Oral Rinse in Xerostomia, sponsored by Sunstar Americas. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by Sunstar Americas · Not applicable, Interventional, and Treatment
Among 88 studies in Xerostomia with a site in United States — 8 open to participants now, 14 under way, 2 of them phase 3. Xerostomia · United States.
Among the 88 studies in Xerostomia with a site in United States, this one is the 31st largest by enrollment of the 73 interventional ones that give a count, is one of 5 that started in 2020, is one of 35 with no phase, and was the 64th registered.
286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.
Browse Xerostomia studies →8 of the 88 studies in Xerostomia with a site in United States are open now. Recruiting first, the newest first:
National Institute of Dental and Craniofacial Research (NIDCR) · Sites in United States
Ages 18–75
RiboX Therapeutics Ltd. · Sites in United States
Ages 18+
University of Wisconsin, Madison · Sites in United States
Ages 18–90
Case Western Reserve University · Sites in United States
Ages 55+ · Healthy volunteers
University of Rochester · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 26 Xerostomia studies recruiting now, 15 (58%) set no upper age limit and 7 (27%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 22 · Phase 3 3 · Phase 4 1
First in 1979; this study’s year is marked. 5 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 39 is below the median of 44 across 235 interventional studies indexed under Xerostomia.
Median enrollment 30 across the 73 interventional studies, 100 across the 15 observational. Of the 69 that completed or were terminated, 30 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 88 have an industry lead sponsor. The 10 most frequent:
Sunstar Americas is the lead sponsor of 10 studies on the registry; none are open to participants now.
Sunstar Americas has 1 study filed under Xerostomia — fewer than ten, so there is no comparison to draw.
6 of the studies in Xerostomia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01266044Phase 3M.D. Anderson Cancer CenterControlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia | 2026-12-31 |
| NCT07771907Access Business GroupNew Functional Ingredient for Oral Care | 2026-12 |
| NCT05060341MeiraGTx, LLCLong-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia | 2027-03 |
| NCT06928142Otsuka Pharmaceutical Development & Commercialization, Inc.A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's | 2027-03-13 |
| NCT06714253RiboX Therapeutics Ltd.Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1 | 2027-08 |
Add all 6 to your calendar (.ics) → With an account.
Among the 88 studies in Xerostomia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.
Device: HYDRAL Oral Rinse · Device: BIOTENE® Oral Rinse · Device: Placebo Oral Rinse
Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.
Device: HYDRAL Oral Rinse · Device: BIOTENE® Oral Rinse · Device: Placebo Oral Rinse
Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.
Device: HYDRAL Oral Rinse · Device: BIOTENE® Oral Rinse · Device: Placebo Oral Rinse
Application 4 times a day for two weeks
Application 4 times a day for two weeks
Application 4 times a day for two weeks
Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline
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.
Time frame: Baseline, 14 days
Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline
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).
Time frame: Baseline, 14 days
Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline
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).
Time frame: Baseline, 14 days
Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline
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.
Time frame: Baseline, 14 days
| Milestone | HYDRAL Oral Rinse - Placebo Oral Rinse - Biotene Oral Rinse | Placebo Oral Rinse - Biotene Oral Rinse - HYDRAL Oral Rinse | BIOTENE Oral Rinse - HYDRAL Oral Rinse - Placebo Oral Rinse |
|---|---|---|---|
| Started | 13 | 13 | 13 |
| First intervention (2 weeks) | 13 | 13 | 11 |
| Washout (1 week) | 13 | 13 | 11 |
| Second intervention (2 weeks) | 13 | 13 | 11 |
| Washout (1 week) | 13 | 13 | 11 |
| Third intervention (2 weeks) | 13 | 13 | 11 |
| Completed | 13 | 13 | 11 |
| Not completed | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 2 |
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.
| mm | HYDRAL Oral Rinse | Placebo Oral Rinse | BIOTENE® Oral Rinse |
|---|---|---|---|
| Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline | 10.1 ± 2.5 | 11.6 ± 3.9 | 13.0 ± 3.2 |
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).
| Score on a scale | HYDRAL Oral Rinse | Placebo Oral Rinse | BIOTENE® Oral Rinse |
|---|---|---|---|
| Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline | 1.0 ± 2.8 | 0.4 ± 1.7 | 0.5 ± 1.5 |
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).
| Score on a scale | HYDRAL Oral Rinse | Placebo Oral Rinse | BIOTENE® Oral Rinse |
|---|---|---|---|
| Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline | 2.0 ± 1.3 | 0 ± 1.7 | 1.2 ± 1.5 |
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.
| mL/min | HYDRAL Oral Rinse | Placebo Oral Rinse | BIOTENE® Oral Rinse |
|---|---|---|---|
| Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline | 0.08 ± 0.11 | 0.00 ± 0.08 | 0.05 ± 0.12 |
Collected over 14 days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HYDRAL Oral Rinse | 0/37 (0%) | 0/37 (0%) | 2/37 (5.4%) |
| Placebo Oral Rinse | 0/37 (0%) | 0/37 (0%) | 2/37 (5.4%) |
| BIOTENE® Oral Rinse | 0/37 (0%) | 0/37 (0%) | 6/37 (16.2%) |
| Event | HYDRAL Oral Rinse | Placebo Oral Rinse | BIOTENE® Oral Rinse |
|---|---|---|---|
| Oral mucosal irritationGastrointestinal disorders | 1/37 | 2/37 | 5/37 |
| Urinary tract infectionInfections and infestations | 1/37 | 0/37 | 0/37 |
| SneezingRespiratory, thoracic and mediastinal disorders | 0/37 | 0/37 | 1/37 |
| Age, Continuous(years) | Overall Participants |
|---|---|
| Mean | 58.2 ± 12.6 |
| Sex: Female, Male(Participants) | Overall Participants |
|---|---|
| Female | 23 |
| Male | 16 |
| Race (NIH/OMB)(Participants) | Overall Participants |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 30 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Overall Participants |
|---|---|
| United States | 39 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2020 to primary completion in Feb 2021, 5 months.
Results were first posted in Feb 2022, 1 year after primary completion.
Of 101 interventional studies with no phase under Xerostomia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 33. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sunstar Americas