A randomiszed, mono-center, placebo-controlled, double-blind, comparative study to evaluate the efficacy and safety of Dynexan® Mundgel in minors with acute painful sites of the mouth

• Conditions: Painful sites in the mouth; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2011-005336-25-DE
• Lead Sponsor: Chemische Fabrik Kreussler & Co. GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-31
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified