임상 레이더 AI | ||
|---|---|---|
임상시험 NCT06268054 (LIBERTÀ)은(는) 원발성 월경통에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea (LIBERTÀ) 3상 78
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06268054 (LIBERTÀ)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 원발성 월경통에 대해 진행되며, 3상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2025년 2월 1일부터 가능하며, 78명의 참여자를 모집할 예정입니다. EMS이(가) 진행하는 이 연구는 2027년 9월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 2월 22일에 갱신되었습니다.
간단한 개요
The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.
공식 제목
A National, Multicenter, Randomized, Double-blind, Phase III, Crossover Clinical Trial to Assess the Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.
질환명
원발성 월경통기타 연구 식별자
- LIBERTÀ
- DEH113-III-0123
NCT 번호
실제 연구 시작일
2025-02
최신 업데이트 게시
2024-02-22
예상 연구 완료일
2027-09
계획된 등록 인원
78
연구종류
중재연구
단계/상
3상
상태
대상자모집전
주요 목적
치료
설계 할당
무작위배정
중재 모델
교차 설계
맹검 (마스킹)
사중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적DEH113 The patient must take two (2) DEH113 tablets, if pain, up to three times a day. | DEH113 Tablets |
위약 대조군Control The patient must take two (2) DEH113 placebo tablets, if pain, up to three times a day. | 위약 비교군 Tablets |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose | Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-6 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). | 6 hours post-dose |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose | Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-4 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). | 4 and 8 hours post-dose |
Sum of Pain Intensity Difference (SPID) over 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). | 4, 6 and 8 hours post-dose |
Use of rescue medication | Proportion of participants who used rescue medication in the first 24 hours after the first drug intake, amount of rescue medication used in the first 24 hours after the first drug intake, and time elapsed between the last drug intake and the first administration of rescue medication. | 24 hours post-dose |
Number of additional drug intake | Number of additional drug intake during the 24 hours after the first drug intake | 24 hours post-dose |
Patients' Global Impression of Change (PGIC) | Patients' Global Impression of Change (PGIC) will be assessed after 8 hours post-dose or immediately before the intake of rescue medication. | 8 hours post-dose |
Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea | The safety will be evaluated considering the incidence of adverse events (AEs) reported during the study period. | 7 days post dose |
참여 도우미
적격성 기준
연령대
어린이, 성인
최소 연령
16 Years
참여 가능한 성별
여성
- 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.
- 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 < 4 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);
- 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
- 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 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;
EMS