R68.2
Conditions
Interventions
Group 1: test product (ipalat® Hydro Med pastille)
single dose, oral (sucking and chewing)
period of application: maximum 5 minutes
Group 2: control product (Parafilm M 5x5 cm piece)
period of application: maximum 5 minutes
Sponsors
Dr. Pfleger Arzneimittel GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Healthy male, female and diverse subjects at least 18 years of age -Written informed consent -Willingness to actively participate in the study -Dry mouth (xerostomia 10.3.3) at least 40 mm VAS (total length 100 mm, ranging from "not dry" to "extremely dry") -Willingness to avoid heavy sweating (e.g. sauna, sport, swimming) one day prior to the measurements -Willingness not to eat spicy or salty foods, including garlic and onions one day prior to the measurements -Willingness not to consume alcohol extensively in the evening prior to the measurements -Willingness to avoid excitement (e.g. exams, tests) in the morning prior to the measurements -Willingness to avoid food with a saliva reducing effect (e.g. alcohol, caffeine-containing beverages, sugar-containing beverages with carbonic acid) 4 hours prior to the measurements -Willingness to avoid food with a saliva stimulating effect (e.g. citrus fruits, chewing gums, chamomile, sage, marshmallow root) 4 hours prior to the measurements -Willingness to avoid food requiring extensive chewing (e.g. carrots, apples, celery) 4 hours prior to the measurements -Willingness not to smoke 4 hours prior to the measurements -Willingness not to eat or drink (except water) within 90 minutes prior to the measurements -Willingness not to change the prosthesis or artificial dentition throughout the course of the study -Willingness to inform the study site in case of changes in therapies especially regarding the medication which caused xerostomia -Negative urine pregnancy test (in female subjects of child bearing potential).
Exclusion criteria
Exclusion criteria: -Poor general health condition -Pregnancy or lactation -Drug addicts, alcoholics, AIDS or infectious hepatitis if known to the subjects -Conditions which exclude a participation or might influence the test reaction/evaluation -Active disease at test area -Subjects suffering from diseases of the salivary glands -Subjects suffering of dental or other problems within the oral cavity -Subjects with chewing or swallowing Problems -Systemic therapy with immuno-suppressive drugs and/or antihistamines within the last 7 days (long-term therapy for at least 3 months is allowed) -Xerostomia developed recently (less than 3 months) or due to short term drug intake -Therapy with antibiotics within the last 2 weeks and/or ongoing -Ongoing radiation or chemotherapy throughout the course of the study -Surgery in test area within the last 4 weeks -Fever or gastrointestinal infection within the last 7 days prior to the start of the study -regular intake (=4/d) of chewing gum or pastilles within 2 weeks prior study start -Prosthesis or artificial dentition within the last 4 weeks prior the start of the study and throughout the course of the study -Smoking within the last 4 hours before the scheduled visits -Intake of any food or beverages (except water) within the 90 minutes prior to the measurements -Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary enpoint is the total salivary flow rate determined after 10 minutes (g/10min) by weighing the tubes containing the collected saliva | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary enpoints: -mean salivary flow rate over 2.5 minute-period [g/2.5 min], 5 minute-period [g/5 min] and 7.5 minute-period [g/7.5 min] -tensiometry: after completion of sucking the investigational device or control and further 2.5 minutes waiting, salivary surface tension [mN/m] will be measured in saliva samples by tensiometry -Assessment of symptom dry mouth (subject) on a visual analogue scale (0mm=not dry - 100mm=extremely dry) -Assessment of local tolerability (Investigator) on the scale: 0=absent; 1=mild, 2=moderate; 3=severen; n.d.=not done -Raman Spectroscopy: small droplets of the saliva will be applied to the glass plate of the RiverD Raman spectrometer to assess if ipalat® Hydro Lutschpastille is available in the saliva sample (result: "yes" or "no"; time points baseline, 5 minutes, 7.5 minutes, 10 minutes) -Subjective Tolerability Assessment (subject) for each of the parameters (tension sensation, burning, tickling sensation) on the scale: 0=None; 1=mild and intermittent; 2=moderate or continuously; 3=severe (independent of duration), 4=intermittently insufferable (> 5min); 5=continuously insufferable; n.d.=not done; -documentation of adverse events | — |
Countries
Germany
Contacts
Public ContactK. Deuble-Bente
proDERM Institut für Angewandte Dermatologische Forschung GmbH
Outcome results
None listed