Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Reduction of intensity (VAS) of composite-pain
研究概览
简要总结
This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for the treatment of pain in patients suspected endometriosis. It is hypothesized that the reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen, is significantly greater than that of Control. In addition, the administration of DLBS1442 at higher dose also results in significantly greater reduction than that of DLBS1442 at lower dose and of Control.
详细描述
There will be three groups of treatment by dosage regimen in this study. Eligible subjects will be randomized to receive any of the following regimens: 1) DLBS1442 at a dose of 3 x 100 mg daily, or 2) DLBS1442 at a dose of 3 x 200 mg daily; or 3) mefenamic acid at a dose of 3 x 500 mg daily. DLBS1442 will be taken every day along the study period (8 weeks), while mefenamic acid will only be taken for five (5) days during the menstrual period, i.e. day 1st to day 5th of menstrual period. Study treatment will be given at a standardized starting point for all subjects, i.e. on the first day of their respective menstrual periods. Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and every 4-week interval throughout the study period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent before any trial related activities
- •Female of 18 - 50 years of age
- •Subjects suspected with cystic endometriosis or adenomyosis confirmed by transvaginal ultrasonography (or transrectal ultrasonography for unmarried subjects)
- •Presence of moderate or severe pain as shown by VAS score of at least 4 on at least one of the following pain: menstrual pain (dysmenorrhea), dyspareunia, non-menstrual pelvic pain, dysuria, dyschezia
- •Occurrence of at least 3 last sequential menstrual cycles of 21 - 35 days duration prior to screening
排除标准
- •Pregnancy
- •Patients with infertility who are willing to be pregnant
- •Using hormonal contraception or other forms of hormonal therapy within the last 30 days
- •Being under therapy with systemic corticosteroids on a chronic or regular basis within the last 90 days
- •History or presence of suspected malignancy abnormalities
- •History of surgical treatment for endometriosis within 3 months prior to screening
- •History of hysterectomy or oophorectomy
- •Presence of clinical signs of sexually transmitted disease
- •Presence of unexplained uterine or cervical bleeding
- •Impaired liver function: serum ALT > 2.5 times upper limit of normal
- •Impaired renal function: serum creatinine >= 1.5 times upper limit of normal
- •Known or suspected allergy to similar products
研究组 & 干预措施
DLBS1442 200
DLBS1442 capsules 3x200 mg daily, taken every day along the study period
干预措施: DLBS1442 200 (Drug)
DLBS1442 100
DLBS1442 capsules 3x100 mg daily, taken every day along the study period
干预措施: DLBS1442 100 (Drug)
Mefenamic acid
Mefenamic acid tablets 3 x 500 mg daily, only taken for five (5) days during the menstrual period, i.e. day 1st to day 5th of menstrual period.
干预措施: Mefenamic acid (Drug)
结局指标
主要结局
Reduction of intensity (VAS) of composite-pain
时间窗: Week 8
Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
次要结局
- Vital signs(Week 4, week 8)
- Routine hematology(Week 8)
- Reduction of the intensity of each pain (VAS)(Week 4, week 8)
- Improvement of quality of life(Week 4, week 8)
- Serum CA-125(Week 8)
- Number of rescue medication(During the course of the study)
- Pain-free period(During the course of the study)
- Percentage or proportion of subjects who complete the study(Week 8)
- hs-CRP(Week 8)
- Response rate(Week 8)
- IL-6(Week 8)
- Adverse event(During the course of the study)
- ECG(Week 8)
- Reduction of intensity (VAS) of composite-pain(4 weeks)
- Liver function(Week 8)
- Renal function(Week 8)