Drug-induced XerostomiaNCT02005328
Exploratory Study in the Relief of Drug-induced Xerostomia Associated With Hyposialia
A study testing Tested product : DC161-DP0291, Tested product : DC161-DP0292 and Tested product : DC161-DP0293 in people with Drug-induced Xerostomia, run by Pierre Fabre Medicament at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia associated with hyposialia, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-induced Xerostomia
- What is being tested?
- Tested product : DC161-DP0291, Tested product : DC161-DP0292 and Tested product : DC161-DP0293
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to Feb 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects,
- Adult subjects (≥18 years) taking drug(s) causing salivary hypofunction / xerostomia, for at least 1 week prior to study initiation and expected to continue without change during study
- Subjects with a complaint of dry mouth as assessed by a response of 40mm or greater on item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale (VAS) questions. (The VAS limits will be 0 representing normal [i.e. no dry mouth symptoms] and 100 representing "the worst imaginable" dry mouth symptoms). This score should also be met before the 1st product application, on P1 D1.
- Documented hyposalivation with test of resting saliva weight absorbed ≤ 0.5g/5 min at baseline
Who cannot join
- Presence of disorders (bucco-dental disease, history of major medical/psychiatric illness or surgery, ... ) which, in the judgement of the investigator, may interfere with study implementation and/or study parameter assessment(s).
- Sjögren syndrome and related autoimmune diseases,
- Other medical causes of xerostomia (oral candidiasis).
- History of head and neck irradiation and cancer chemotherapy
- History of hypersensitivity to any of the components of the investigational products,
- History or current excessive use of alcohol,
- History of drug addiction,
- Presence of treatments for their dry mouth within 7 days prior to inclusion into the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect and Safety of Three New Oral Sprays and a Reference Marketed Oral Spray in the Relief of Drug-induced Xerostomia Associated With Hyposialia.
The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation (hyposialia) induced by chronic drug intake.
- Conditions
- Drug-induced Xerostomia
- Being tested
- Tested product : DC161-DP0291, Tested product : DC161-DP0292, Tested product : DC161-DP0293, Reference product: solution for oromucosal sprays
- Keywords
- Xerostomia, hyposialia, hyposalivation, saliva substitute, Salivary Gland, Mouth Diseases, Dry mouth
- Medical subject headings
- Xerostomia, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tested product : DC161-DP0291Device
Application of product in the mouth twice daily
Tested product : DC161-DP0292Device
Application of product in the mouth twice daily
Tested product : DC161-DP0293Device
Application of product in the mouth twice daily
Reference product: solution for oromucosal spraysDevice
Application of product in the mouth twice daily
| Study group | Role | What they receive |
|---|---|---|
| cross-over | Experimental | Four periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days. Receives: Device: Tested product : DC161-DP0291; Device: Tested product : DC161-DP0292; Device: Tested product : DC161-DP0293; Device: Reference product: solution for oromucosal sprays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed area under the curve of dry mouth evaluations
Dry mouth will be self-rated using item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale questions.
Measured: 11 points : from baseline (before application) and up to 4 hours after the first product application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-induced 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005328
- Sponsor's protocol ID
- DC0161 BS 0 01
- Other IDs
- CIV-13-10-011648
- Status last verified
- Apr 2014
- First submitted
- 3 Dec 2013
- Last updated
- 15 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect and Safety of Three New Oral Sprays and a Reference Marketed Oral Spray in the Relief of Drug-induced Xerostomia Associated With Hyposialia.
- ClinicalTrials.gov ID
- NCT02005328
- Acronym / sponsor ID
- DC0161 BS 0 01
- Conditions
- Drug-induced Xerostomia
- Keywords
- Xerostomia, hyposialia, hyposalivation, saliva substitute, Salivary Gland, Mouth Diseases, Dry mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Dec 2013 (estimated)
- 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.
The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation (hyposialia) induced by chronic drug intake.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cross-over | Experimental | Device: Tested product : DC161-DP0291, Device: Tested product : DC161-DP0292, Device: Tested product : DC161-DP0293, Device: Reference product: solution for oromucosal spraysFour periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects,
- Adult subjects (≥18 years) taking drug(s) causing salivary hypofunction / xerostomia, for at least 1 week prior to study initiation and expected to continue without change during study
- Subjects with a complaint of dry mouth as assessed by a response of 40mm or greater on item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale (VAS) questions. (The VAS limits will be 0 representing normal [i.e. no dry mouth symptoms] and 100 representing "the worst imaginable" dry mouth symptoms). This score should also be met before the 1st product application, on P1 D1.
- Documented hyposalivation with test of resting saliva weight absorbed ≤ 0.5g/5 min at baseline
Key exclusion criteria (8 listed)
- Presence of disorders (bucco-dental disease, history of major medical/psychiatric illness or surgery, ... ) which, in the judgement of the investigator, may interfere with study implementation and/or study parameter assessment(s).
- Sjögren syndrome and related autoimmune diseases,
- Other medical causes of xerostomia (oral candidiasis).
- History of head and neck irradiation and cancer chemotherapy
- History of hypersensitivity to any of the components of the investigational products,
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 |
|---|---|---|
| Tested product : DC161-DP0291Application of product in the mouth twice daily | Device | cross-over |
| Tested product : DC161-DP0292Application of product in the mouth twice daily | Device | cross-over |
| Tested product : DC161-DP0293Application of product in the mouth twice daily | Device | cross-over |
| Reference product: solution for oromucosal spraysApplication of product in the mouth twice daily | Device | cross-over |
Primary outcome
Observed area under the curve of dry mouth evaluations
Time frame: 11 points : from baseline (before application) and up to 4 hours after the first product application
Dry mouth will be self-rated using item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale questions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tested product : DC161-DP0291, Tested product : DC161-DP0292 and Tested product : DC161-DP0293 in people with Drug-induced Xerostomia, run by Pierre Fabre Medicament at 1 site in Germany.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed area under the curve of dry mouth evaluations (time frame: 11 points : from baseline (before application) and up to 4 hours after the first product application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2014.