Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Visual analogue Score (VAS) 1-100 for pain
研究概览
简要总结
The purpose of this study is to evaluate if baclofen vaginal suppositories improve symptoms of Chronic Pelvic Pain (CPP).
Participants in this study will take four short questionnaires prior to being randomized. Randomization is like flipping a coin; participants have an equal likelihood of being randomized to the treatment group (vaginal baclofen suppositories) or placebo group (vaginal suppository without baclofen ingredient). Participants will take their assigned treatment nightly for 8 weeks. Follow up visits will be at the 4 and 8 week time frames, when questionnaires will again be completed. Participants may receive additional treatments for CPP during the course of the study. After 8 weeks Participants will be offered a prescription for baclofen suppositories and the study drug will be stopped. Follow up on patient symptoms with questionnaires will again occur at 12 weeks.
详细描述
Study Design/Methodology
This is a single center, double-blinded, placebo-controlled, randomized trial. Women will be recruited from a subspecialty clinic at the University of Louisville and be eligible for participation if they meet the diagnosis of Chronic Pelvic Pain and are between the ages of 18-65 years old. Eligible, consenting participants will undergo randomization with equal probability of assignment to one of the two groups:
- Baclofen 20mg vaginal suppository daily per vagina and
- placebo.
Participants will be blinded to study allocation. Baclofen or placebo suppositories will be continued to 8 weeks, at which time all participants will be offered a baclofen suppository prescription. Patients will then follow up at the 12 week mark and whether they continued baclofen suppositories and pill count will be recorded in addition to the below questionnaires.
Clinical outcomes and questionnaires will be assessed at baseline and after 4, 8, and 12 weeks of treatment. Participants will be randomized with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants).
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)
盲法说明
Randomization will be carried out by a computer-based algorithm that will generate study/subject number. This number will correspond with treatment and communicate to The Louisville compounding pharmacy the appropriate drug to distribute without the unblinding of patient or provider. with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants). Randomization will be stratified based on pelvic muscle tenderness on exam - stratifying by 0-5/10 and 6-10/10 tenderness of pelvic floor musculature on physical exam
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ages 18-65 years old
- •Women are not sexually active, sexually active with same sex partners or are on effective contraception
- •Diagnosed with Chronic Pelvic Pain
排除标准
- •Gross hematuria
- •Currently pregnant or breastfeeding
- •Unable to speak and read English
- •History of allergic reaction to baclofen tablet
- •History of allergic reaction to components of placebo (coconut oil)
- •History of gastrointestinal, genitourinary, or pelvic cancer in the last 5 years
研究组 & 干预措施
Vaginal baclofen suppository
Baclofen 20mg in Supposibase F vaginal suppository daily per vagina
干预措施: 20 mg baclofen vaginal suppository daily per vagina (Drug)
Vaginal placebo suppository
Supposibase F vaginal suppository daily per vagina
干预措施: Placebo (Drug)
结局指标
主要结局
Visual analogue Score (VAS) 1-100 for pain
时间窗: at 8 weeks of suppository use
VAS is a 1-100mm scale with lower scores indicating less pain
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score(at baseline and at 4, 8 and 12 weeks)
- Pelvic floor impact questionnaire(at baseline and at 4, 8, and 12 week follow up)
- Pelvic floor disability index (PFDI) questionnaire(at baseline and at 4, 8, and 12 week follow up)
- Visual analogue Score (VAS) 1-100 for pain(at baseline and at 4 and 12 week follow up)
- O'Leary Sant questionnaire(at baseline and at 4, 8, and 12 week follow up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) global health score(at baseline and at 4, 8, and 12 week follow up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score(at 0, 4, 8, and 12 week follow up)
- Overall Satisfaction(at 4, 8, and 12 week follow up)
- Number of other treatments for chronic pelvic pain during the trial period(at 4, 8, and 12 week follow up)
- Pill Count(at 4, 8, and 12 week follow up)
研究者
Ankita Gupta
Principal Investigator
University of Louisville