E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Teething in babies which can lead to symptoms like irritability, rash, and severe pain. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052001 |
E.1.2 | Term | Teething pain |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of Dynexan® Mundgel for the treatment of acute pain due to teething in comparison to placebo. |
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E.2.2 | Secondary objectives of the trial |
To collect safety information about the use of Dynexan® Mundgel in teething subjects. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study is reached with last patient last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |