NCT06555549尚未招募不适用
A National, Multicenter, Randomized, Double-blind, Single-dose, Crossover Clinical Trial to Preliminary Evaluate the Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramps Pain Associated With Primary Dysmenorrhea
EMS0 个研究点目标入组 60 人开始时间: 2024年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 and 0-8 hours post-dose
研究概览
简要总结
This study aims to evaluate the preliminary efficacy and safety of DEH113 in the Treatment of Menstrual Cramps Pain Associated with Primary Dysmenorrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has given written informed consent to participate in the study before admission to the study;
- •Female patients aged between 16 and 35 years old, inclusive;
- •History of regular menstrual cycles, occurring between every 21 to 35 days;
- •Clinical history compatible with the diagnosis of primary dysmenorrhea;
- •Self-reported history of ≥ 4 painful cycles, with moderate or severe menstrual cramps, in the six (06) months prior to selection for the study.
排除标准
- •Diagnosis of secondary dysmenorrhea;
- •History of non-response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to relieve menstrual cramps;
- •Onset of primary dysmenorrhea after starting to use oral contraceptives;
- •Use of oral contraceptives for < 3 months prior to study selection;
- •Use of an intrauterine device (IUD), hormonal implants, or contraceptive injections in the last six (06) months;
- •Previous diagnosis or physical examination findings and/or clinical and/or surgical history that may indicate the presence of endometriosis, pelvic inflammatory disease, adenomyosis, mullerian duct malformation, uterine fibroma, cystic ovary and/or pelvic varicocele;
- •History of recurrent pelvic and/or lower abdominal pain outside the menstrual period;
- •Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial;
- •History of hypersensitivity reactions, such as asthma attacks or other types of allergic reactions, to acetylsalicylic acid or other NSAIDs;
- •Previous diagnosis of glaucoma;
- •Previous diagnosis of kidney and/or liver failure;
- •Presence of blood dyscrasias and situations of bone marrow suppression;
- •Diagnosis of acute intermittent hepatic porphyria;
- •Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD);
- •Previous diagnosis of acute intermittent hepatic porphyria;
- •Presence of mechanical stenosis in the gastrointestinal tract;
- •Previous diagnosis of paralytic ileus or intestinal atony
- •Diagnosis of myasthenia gravis;
- •Previous diagnosis of severe ulcerative colitis or toxic megacolon complicated with ulcerative colitis
- •Treatment with psychoactive drugs (such as for example, antidepressants, antipsychotics, etc.) in the 30 days prior to selection for the study;
- •Participants with a history of alcohol or illicit drug use disorder in the last two (02) years;
- •Participants with a current medical history of cancer and/or cancer treatment in the last five (05) years;
- •Any finding of clinical observation (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or the presence of uncontrolled chronic disease(s);
- •Participants who are pregnant, nursing, or planning to become pregnant;
- •Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it;
研究组 & 干预措施
DEH113
Experimental
The patient must take two (2) DEH113 tablets in a single dose, if pain.
干预措施: DEH113 (Drug)
Placebo
Placebo Comparator
The patient must take two (2) placebo tablets in a single dose, if pain.
干预措施: Placebo (Drug)
结局指标
主要结局
Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 and 0-8 hours post-dose
时间窗: 4, 6 and 8 hours post-dose
Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4, 0-6 and 0-8 hours post-dose. Pain relief will be evaluate using a Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose
时间窗: 4, 6 and 8 hours post-dose
Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose. The pain intensity will be assessed using a Categorical 4-point scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain).
次要结局
- Patients' Global Impression of Change (PGIC)(8 hours post-dose)
- Pain intensity (PI) over time(0, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose)
- Use of rescue medication(8 hours post-dose)
研究者
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