XEROSTOMIAPhase 1XEROSTOMIANCT04184908
Clinical Study New Gel for Xerostomia
A Phase 1 study testing gel xerostomia in people with XEROSTOMIA, run by Universidad de Murcia at 2 sites in Spain.
Trial summary
At present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. Current therapy for the control of xerostomia is based on the following measures: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- XEROSTOMIA
- What is being tested?
- gel xerostomia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Oct 2019to 31 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects of both sexes 2. Over 18 years. 3. Adequate cultural level and understanding of the clinical study. 4. Agree to voluntarily participate in the study and give their informed consent in writing 5. Present xerostomia of more than three months of evolution / sialometry less than 0.2ml / 5 min.
Who cannot join
- The presence of at least one of the following criteria will be grounds for exclusion from the clinical trial:
- Presence of health problems that may compromise adherence to the study protocol.
- Pregnant or breastfeeding women.
- Present hypersensitivity to any component of the product under study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Lopez-Jornet Pia
Murcia, N/A = Not Applicable, 30008
Lopez-Jornet Pia, 639473308, majornet@um.es
- Not yet recruiting
Lopez-Jornet Pia
Murcia, N/A = Not Applicable, 30008
Lopez-Jornet Pia, 639473308, majornet@um.es
About this study
Official title: Clinical Study to Evaluate the Efectiveness and Tolerability of a New Gel for Xerostomia
At present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. Current therapy for the control of xerostomia is based on the following measures:
- General measures ; review and control of drugs,hydration and dietary advice: The main recommendations are found in the following scheme.
- Saliva stimulants( Topics and sistemic )The option of using chewing stimuli by chewing gum with non-cariogenic sweeteners helps to improve symptoms. The investigators can also use gustatory stimuli, such as citric acid that is a potent stimulator of salivary secretion. Among the most commonly used pharmacological agents are: pilocarpine, bethanecol, civemiline
- Saliva substitutes or artificial saliva. Saliva substitutes can provide a moisture retention layer in the oral mucosa and can be administered by liquids, spray, pills or gels. Topical treatments have few adverse effects and improve the quality of life of patients with xerostomia; In addition, they maintain oral health.
Read the detailed description
Randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability in patients with a non-commercialized gel and property of the promoter to treat xerostomia.
- Conditions
- XEROSTOMIA
- Being tested
- gel xerostomia, gel placebo
- Keywords
- dry mouth
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gel xerostomiaDrug
Also called lubricant and remineralizing agents
Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night
gel placeboOther
Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night
| Study group | Role | What they receive |
|---|---|---|
| GROUP EXPERIMENTAL | Experimental | Gel xerostomia Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night Receives: Drug: gel xerostomia |
| CONTROL GROUP | Placebo comparator | Gel placebo Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night Receives: Other: gel placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHIP 14
Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases
Measured: 1moth
Sialometry
Drenaje
Measured: 1moth
Test Thonsom xerostomy
Xerostomia Inventory. the higher the outcome, quality of life decreases
Measured: 1moth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Oct 2019
- Primary completion2 Nov 2019
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for XEROSTOMIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Lopez Jornet, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184908
- Sponsor's protocol ID
- UNIVERSITY
- Acronym
- XEROSTOMIA
- Status last verified
- Dec 2019
- First submitted
- 29 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Assery MKA. Efficacy of Artificial Salivary Substitutes in Treatment of Xerostomia: A Systematic Review. J Pharm Bioallied Sci. 2019 Feb;11(Suppl 1):S1-S12. doi: 10.4103/jpbs.JPBS_220_18.
PubMed 30923424Gil-Montoya JA, Silvestre FJ, Barrios R, Silvestre-Rangil J. Treatment of xerostomia and hyposalivation in the elderly: A systematic review. Med Oral Patol Oral Cir Bucal. 2016 May 1;21(3):e355-66. doi: 10.4317/medoral.20969.
PubMed 27031061Lysik D, Niemirowicz-Laskowska K, Bucki R, Tokajuk G, Mystkowska J. Artificial Saliva: Challenges and Future Perspectives for the Treatment of Xerostomia. Int J Mol Sci. 2019 Jun 29;20(13):3199. doi: 10.3390/ijms20133199.
PubMed 31261876
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efectiveness and Tolerability of a New Gel for Xerostomia
- ClinicalTrials.gov ID
- NCT04184908
- Acronym / sponsor ID
- XEROSTOMIA / UNIVERSITY
- Conditions
- XEROSTOMIA
- Keywords
- dry mouth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 2 Nov 2019 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. Current therapy for the control of xerostomia is based on the following measures:
- General measures ; review and control of drugs,hydration and dietary advice: The main recommendations are found in the following scheme.
- Saliva stimulants( Topics and sistemic )The option of using chewing stimuli by chewing gum with non-cariogenic sweeteners helps to improve symptoms. The investigators can also use gustatory stimuli, such as citric acid that is a potent stimulator of salivary secretion. Among the most commonly used pharmacological agents are: pilocarpine, bethanecol, civemiline
- Saliva substitutes or artificial saliva. Saliva substitutes can provide a moisture retention layer in the oral mucosa and can be administered by liquids, spray, pills or gels. Topical treatments have few adverse effects and improve the quality of life of patients with xerostomia; In addition, they maintain oral health.
Detailed description
Randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability in patients with a non-commercialized gel and property of the promoter to treat xerostomia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP EXPERIMENTAL | Experimental | Drug: gel xerostomiaGel xerostomia Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night |
| CONTROL GROUP | Placebo comparator | Other: gel placeboGel placebo Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects of both sexes 2. Over 18 years. 3. Adequate cultural level and understanding of the clinical study. 4. Agree to voluntarily participate in the study and give their informed consent in writing 5. Present xerostomia of more than three months of evolution / sialometry less than 0.2ml / 5 min.
Key exclusion criteria (4 listed)
- The presence of at least one of the following criteria will be grounds for exclusion from the clinical trial:
- Presence of health problems that may compromise adherence to the study protocol.
- Pregnant or breastfeeding women.
- Present hypersensitivity to any component of the product under study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gel xerostomiaAlso: lubricant and remineralizing agentsApply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night | Drug | GROUP EXPERIMENTAL |
| gel placeboApply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night | Other | CONTROL GROUP |
Primary outcome
OHIP 14
Time frame: 1moth
Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases
Sialometry
Time frame: 1moth
Drenaje
Test Thonsom xerostomy
Time frame: 1moth
Xerostomia Inventory. the higher the outcome, quality of life decreases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Background: PubMed 30923424Assery MKA. Efficacy of Artificial Salivary Substitutes in Treatment of Xerostomia: A Systematic Review. J Pharm Bioallied Sci. 2019 Feb;11(Suppl 1):S1-S12. doi: 10.4103/jpbs.JPBS_220_18.
- Background: PubMed 27031061Gil-Montoya JA, Silvestre FJ, Barrios R, Silvestre-Rangil J. Treatment of xerostomia and hyposalivation in the elderly: A systematic review. Med Oral Patol Oral Cir Bucal. 2016 May 1;21(3):e355-66. doi: 10.4317/medoral.20969.
- Background: PubMed 31261876Lysik D, Niemirowicz-Laskowska K, Bucki R, Tokajuk G, Mystkowska J. Artificial Saliva: Challenges and Future Perspectives for the Treatment of Xerostomia. Int J Mol Sci. 2019 Jun 29;20(13):3199. doi: 10.3390/ijms20133199.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gel xerostomia in people with XEROSTOMIA, run by Universidad de Murcia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pia López-Jornet, PhD (639473308, majornet@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OHIP 14 (time frame: 1moth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04184908, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.