NCT05640232招募中3 期
A National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III, Crossover Study to Assess the Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.
EMS1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2025年6月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Sum of Total Pain Relief (TOTPAR) over 0-4 hours post-dose.
研究概览
简要总结
The purpose of this study if to evaluate the efficacy and safety of CDE100 in the Treatment of Menstrual Cramp 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)
盲法说明
Double-blind, Double-dummy.
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 prior to admission to the study;
- •Female patients aged between 16 and 35 years old, inclusive;
- •History of regular menstrual cycles, occuring 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;
- •History or diagnosis of peptic/hemorrhagic ulcer;
- •History of gastrointestinal bleeding or perforation related to the use of NSAIDs;
- •Presence of compromised bone marrow function or diseases of the hematopoietic system;
- •Diagnosis of acute intermittent hepatic porphyria;
- •Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD);
- •Diagnosis of untreated angle-closure glaucoma;
- •Presence of mechanical stenosis in the gastrointestinal tract;
- •Diagnosis of megacolon and/or paralytic or obstructive ileus;
- •Diagnosis of myasthenia gravis;
- •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;
- •Presence of any serious illness, at the discretion of the investigator;
- •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 presence of uncontrolled chronic disease(s);
- •Participants who are pregnant, nursing or planning to become pregnant;
- •Disagreement with the use of a known effective barrier contraceptive method, unless using a stable oral contraceptive for three months or more (which must be maintained throughout the study), or surgically sterile or who expressly declare themselves exempt from risk of pregnancy for not exercising sexual practices or exercising them in a non-reproductive manner;
- •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;
- •Presence of any condition that, at the discretion of the investigator, makes the patient unfit to participate in the study.
研究组 & 干预措施
Experimental
Experimental
CDE100 The patient must take 1 pill of CDE100 association and placebo of Buscopan® Composto association, if pain, until three times a day.
干预措施: CDE100 association (Drug)
Control
Active Comparator
Buscopan® Composto association.
The patient must take 1 pill of Buscopan® Composto association and placebo of CDE100 association, if pain, until three times a day.
干预措施: Buscopan® Composto association (Drug)
结局指标
主要结局
Sum of Total Pain Relief (TOTPAR) over 0-4 hours post-dose.
时间窗: 4 hours post-dose.
Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4 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).
次要结局
- Sum of Total Pain Relief (TOTPAR) over 0-8 hours post-dose.(8 hours post-dose.)
- Sum of Pain Intensity Difference (SPID) over 4 hours post-dose.(4 hours post-dose.)
- Sum of Pain Intensity Difference (SPID) over 8 hours post-dose.(8 hours post-dose.)
- Time to first intake of rescue medication.(Up to 8 hours post-dose.)
- Patients who used rescue medication.(Up to 8 hours post-dose.)
- Number of additional drug intake.(3 days.)
- Patients' Global Impression of Change (PGIC).(8 hours.)
- Evaluate the safety of CDE100 association in the treatment of primary dysmenorrhea.(Up to 175 days.)
- Doses of rescue medication used.(Up to 8 hours post-dose.)
研究者
研究点 (1)
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