Painful sites in the mouth
Conditions
Interventions
Trade Name: Dynexan Mundgel
Product Name: Dynexan Mundgel
Pharmaceutical Form: Gel
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Concentration unit: mg/g milligram(s)/gram
Concentration type: eq
Sponsors
Chemische Fabrik Kreussler & Co. GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects, from 6 month to 8 years of age at the time of enrollment. 2. Written informed consent of the legal representative. 3. Verbal assent from minors = 4 years, written assent depending on intellectual maturity of the minor. 4. Ability to comply with the requirements of the study. 5. Clinical diagnosis of a painful site / s in the mouth (at least “Face 2 = Hurts little more”) on the Wong-Baker FACES pain scale). The painful site have to be large enough to enable recognizing of pain reduction and may not be to large to for the amount of gel to be applied. 6. At least 2 of the following signs have to be reported by the legal representative at the screening examination: weeping, crying, grouching, mood swings, changes in behavior, and increase in body temperature above normal, sleepiness, or sick feeling. Small infants may appear over-sleepy or inactive, be irritable, vomit or feed poorly. Are the trial subjects under 18? yes Number of subjects for this age range: 222 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in an investigational trial within 30 days prior to enrollment and for the whole study duration. 2. Any current uncontrolled infection. 3. Inflammatory oral and mucosal disease. 4. Known hypersensitivity to lidocaine or any of the ingredients of Dynexan® Mundgel (benzalkonium chloride, aromatic oil, galactomanan, glycerol, paraffin, saccharin sodium, silicon dioxide, thymol, titanium dioxide, vaseline). 5. Known pronounced allergic disposition. 6. Acute severe systemic disease or poor general health. 7. Severe generalized infection. 8. Acute strong febrile states. 9. Subjects with earache, or other painful situations. 10. Teething subjects with cleft palate. 11. Subjects with known history of instable diseases (diabetes, heart failures, etc.), consuming diseases (cancer), heritage diseases, or liver or renal insufficiency. 12. Any chronic or acute condition including the mucosa and skin, susceptible, in the opinion of the investigator, of interfering with the evaluation of the drug effect. 13. Subject with any of the following:· Known Ehlers-Danlos syndrome· Known Attention Deficit Hyperactivity (ADHD) 14. Systemic intake of pain relievers within 8 hours prior to enrollment and for the whole study duration. 15. Any local acting (mouth cavity) medication, including over the counter products and dietary supplements such as iodine, fluoride, or vitamins, which would interfere with study results, within 8 hours before and during the study course. 16. Subjects who are placed in an institution due to a judicial or official directive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the comparison of pain reduction after local application of Dynexan® Mundgel or placebo on painful sites in the mouth. ;Secondary Objective: The main secondary objectives are the evaluation of the safety and local tolerability of Dynexan® Mundgel. ;Primary end point(s): Primary efficacy variable: • Pain reduction from T1 to T2 ;Timepoint(s) of evaluation of this end point: T1: directly prior to study drug administration T2: 10 ± 5 min after study drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pain reduction from T1 to T3 (application – 30 ± 10 min after application) • Comparison of children’s and parent’s assessment, whenever both ratings are eligible • Assessment of subject’s satisfaction (parent’s assessment) as rated on a 5-point verbal rating scale • Characterisation of safety and tolerability of the investigational product considering Adverse Events in the study population, descriptive evaluation • Assessment of local tolerability by the investigator (number of subjects with global tolerability ratings of “very good”, “good”, “moderate”, “poor”, descriptive evaluation ;Timepoint(s) of evaluation of this end point: Pain reduction from T1 to T3: T1: directly prior to study drug administration T3: 30 ± 10 min after study drug administration Assessment of subject’s satisfaction: 1 hour p.a. Characterisation of safety and tolerability of the investigational product considering Adverse Events in the study population, descriptive evaluation: Assessment of global tolerability by the investigator: 1h, and 24 h p.a. | — |
Countries
Germany
Contacts
Public ContactHead of Clinical Department
CardioSec Clinical Research GmbH
Outcome results
None listed