EUCTR2010-021499-27-DE进行中（未招募）不适用
A Prospective, Randomized, Multi-centre, Placebo-controlled, Double blind, Comparative Study To Evaluate the Efficacy and Safety of Dynexan® Mundgel in Subjects with Acute Teething Pain - Dynexan® Mundgel in Teething Babies
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 414
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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