Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
赞助:
NorthShore University HealthSystem Research Institute
合作者:
信息的提供 (责任方):
Frank F. Tu，NorthShore University HealthSystem Research Institute
| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 4, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | May 9, 2018 | ||
| 预计主要完成日期 | May 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Menstrual Pain[ Time Frame: 6-8 months ] Daily Diary data on menstrual pain-is it improved with the use of naproxen? Bladder Pain[ Time Frame: 6-8 months ] Experimental Bladder Pain sensitivity using a naturalistic paradigm-is it improved when menstrual pain is treated with naproxen? |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain | ||
| 正式标题 ICMJE | Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain | ||
| 简要概况 | The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. In addition, we will determine whether cross-organ influences from the uterus on bladder pain sensitivity change from baseline after reduced menstrual pain experience over six months. Finally, a battery of quantitative sensory tests and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with improvements in menstrual and bladder pain. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 4 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | May 1, 2021 | ||
| 预计主要完成日期 | May 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: Reproductive-age women (age 18-45) with dysmenorrhea will be recruited. Cases will have: a) average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic OCs without painkillers, b) menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament, and c) indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs). Participants who endorse bladder symptoms (subclinical urgency, frequency, bladder pain) on the phone screen or bladder symptoms will represent at least 50% of enrolled participants); those who do not endorse bladder symptoms may be determined ineligible. They must not have a formal urological diagnosis such as overactive bladder or painful bladder syndrome. Exclusion Criteria: Includes: a) presence of active pelvic or abdominal malignancies (primary or metastatic), b) absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding), c) active genitourinary infection in the last four weeks, d) unable to read or comprehend the informed consent in English, e) unwilling to complete study procedures, and f) presence of hypertension or risk for developing hypertension, g) unwillingness to take naproxen and/or placebo, h) or contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function). Participants with a history of epilepsy will not complete the visual unpleasantness task. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：45 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Frank F. Tu，NorthShore University HealthSystem Research Institute | ||
| 研究赞助商 ICMJE | NorthShore University HealthSystem Research Institute | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | NorthShore University HealthSystem Research Institute | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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