National, Multicenter, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- To assess the reduction in pain intensity after 3 days of treatment.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Age greater than or equal to 12 years;
- •Minor recurrent aphthous ulceration with onset of symptoms within 48 hours;
- •Moderate to severe baseline pain, with VAS ≥ 4 (EVA scale).
排除标准
- •Any clinical findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Participants diagnosed with: Behcet's disease, rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, Reiter's syndrome, Crohn's disease, ulcerative colitis);
- •Participants with diseases that affect healing (e.g. diabetes);
- •Immunocompromised participants;
- •Participants with aphthous herpetiform ulceration or major aphthous ulceration;
- •Participants using medication to treat oral ulcerations (systemic or local);
- •Participants who used analgesics or anti-inflammatory drugs in the 6 hours prior to the beginning of the study;
- •Participants who used systemic antibiotics in the 2 weeks prior to the beginning of the study;
- •Participants using medications that can confuse pain assessment (psychotropics, antidepressants and sedative-hypnotics), except when on a stable dose for at least 30 days prior to the screening visit, and the dose cannot be changed during the clinical trial;
- •Participants with current smoking habits.
- •Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
- •Known hypersensitivity to the formula components used during the clinical trial;
- •Participants with current or medical history of cancer in the last 5 years;
- •Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.
研究组 & 干预措施
BALI 25 + 25 + 15
Three applications per day or more in case of pain, not exceeding six applications per day. The number of drops varies according to the ulcer diameter: 1 to 3 mm: 1 drop; 3 to 6 mm: 2 drops; greater than 6 mm: 3 drops.
干预措施: BALI association (Drug)
PLACEBO
Three applications per day or more in case of pain, not exceeding six applications per day. The number of drops varies according to the ulcer diameter: 1 to 3 mm: 1 drop; 3 to 6 mm: 2 drops; greater than 6 mm: 3 drops.
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the reduction in pain intensity after 3 days of treatment.
时间窗: 3 days
Difference in pain intensity after 3 days of treatment compared to baseline. Pain intensity will be evaluated by the Visual Analogue Scale (VAS). The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
次要结局
- Percentage of participants with no pain during treatment.(3, 5 and 7 days)
- To assess the reduction in pain intensity during the treatment.(5 and 7 days)
- To assess the reduction in pain intensity after the first application.(15 minutes)
- Percentage of participants healed during treatment.(3, 5 and 7 days)
- To assess the percentage change in pain intensity from baseline during treatment.(3, 5 and 7 days)