Teething in babies which can lead to symptoms like irritability, rash, and severe pain. MedDRA version: 12.1 Level: LLT Classification code 10052001 Term: Teething pain
Conditions
Interventions
Trade Name: Dynexan® Mundgel
Pharmaceutical Form: Gel
CAS Number: 73-78-9
Other descriptive name: LIDOCAINE HYDROCHLORIDE
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentra
Sponsors
Chemische Fabrik Kreussler & Co. GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female teething subjects of age 6-24 months 2. Availability of subjects’ parents (either of the parents)/legally acceptable representative (LAR) who are willing to sign and date written informed consent to participate in the study. However, if the subjects’ parents/LAR is illiterate, the impartial witness will sign the informed consent form (ICF) 3. Subjects with acute teething pain with visible or invisible tooth tips would be included. In case of absence of visible tooth tips even if the signs of teething at the site (redness, discoloration or inflammation of the gingiva) are visible the subjects would be recruited in the trial. The investigators will ascertain that the cause of acute pain is teething. 4. FLACC pain score =7. Are the trial subjects under 18? yes Number of subjects for this age range: 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. Inflammatory oral and mucosal disease 2. 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) 3. Known pronounced allergic disposition 4. Acute severe systemic disease or poor general health 5. Severe generalized infection 6. Acute febrile states of other etiology than teething 7. Subjects with earache 8. Teething subjects with cleft palate 9. Any participation in another clinical study within 4 weeks (30 days) prior to enrolment in this study 10. Parent’s or LAR’s antipathy against treatment procedures, aftercare and the follow-up 11. Drug abuse by the parents 12. Treatment with analgesics (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] or acetaminophene/ paracetamol) within 2 days prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Dynexan® Mundgel for the treatment of acute pain due to teething in comparison to placebo.;Secondary Objective: To collect safety information about the use of Dynexan® Mundgel in teething subjects.;Primary end point(s): The primary efficacy endpoint is the percentage reduction in acute teething pain from T2** to T4*** calculated based on score of pain at T2 and T4 as measured by the Investigator using Face, Legs, Activity, Cry and Consolability (FLACC) scale and disregarding the pain reduction due to placebo effect from T0* to T2. *T0 at Visit 1: Screening assessment **T2 (T= Timepoint) at Visit 1: Assessment of pain by using FLACC score, 10-15 min after first application of placebo gel to exclude subjects that react only to the procedure of application) ***T4 at Visit 1: about 30 min after T2, about 15 min after T3= application of IP/placebo | — |
Countries
Germany
Outcome results
None listed