"A prospective, single-center, Investigator initiated clinical study to evaluate theonset of analgesic effectiveness and safety of combination of Camylofin (50 mg) and nonsteroidalanti-inflammatory agent Mefenamic acid (250 mg) in patients with moderate to severe primaryDysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1. To estimate time of onset of action of Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg tablet in patients with moderate to severe primary dysmenorrhea.
研究概览
简要总结
Dysmenorrhea, defined as painful cramps that occur with menstruation, is the most common gynecologic problem in women of all ages and races, and one of the most common causes of pelvic pain. 1, 2.It is commonly divided into primary dysmenorrhea (pain without organic pathology) and secondary dysmenorrhea (pelvic pain associated with an identifiable pathological condition, such as endometriosis. Studies from India reported the prevalence range between 50 to 87.8% (George & Bhaduri, 2002; Patel, 2006; Nair, 2007; Singh, 2008; Agarwal & Agarwal, 2010). Other studies reported that dysmenorrhea affects up to 90% of women of childbearing age to varying degrees (Weissman, 2004).The rationale of the study is to observe and collect safety and efficacy data on Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg tablet. The analgesic effectiveness will be evaluated by reduction in pain on Visual Analog Scale (VAS) and on Numerical Rating Scale (NRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Perimenopausal women above 18 years of age and below45years of age
- •Female patients with primary dysmenorrhea on the 1st or 2nd day of their current menstrual cycle
- •History of moderate to severe primary dysmenorrhea during four or more of the previous six menstrual cycles on10-point numeric rating scale
- •Patients willing to provide written informed consent
- •Female of childbearing potential must have a negative pregnancy test and be nonlactating at screening visit.
- •Patient is willing to abstain from alcohol consumption throughout the 12-hour Treatment Period.
排除标准
- •Female patients with a history of taking Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg or any other prescription-only and/or non-prescription analgesics, antispasmodics, antidepressants, or antipsychotic medication within the 4 weeks before study enrolment.
- •Patients who are determined as being the risk group for COVID-
- •Female patients on antacids, Antihistaminics, tricyclic antidepressants, phenothiazines, disopyramide, pethidine
- •Female patients taking Ace inhibitors, Asprin, Diuretics, Lithium, Methotrexate, Warfarin
- •Female patients with positive urine pregnancy test
- •Lactating female patients
- •Female patients with a history of irregular menstrual cycle in the last 6 months
- •Female patients with secondary dysmenorrhea (including the following etiologies: leiomyomata [fibroids], pelvic inflammatory disease, tubo-ovarian abscess, ovarian torsion, endometriosis)
- •Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
- •Female patients with a history of upper gastrointestinal bleeding and/or active peptic ulcer
- •Females using an Intrauterine Contraceptive Device (IUCD) or currently using an oral contraceptive for less than 3 months, has been on a unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months or intends to do so in the course of the study
- •Cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments
- •History of hypersensitivity to study drug or any of its ingredients.
结局指标
主要结局
1. To estimate time of onset of action of Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg tablet in patients with moderate to severe primary dysmenorrhea.
时间窗: 1. Day 1 to day 2
次要结局
- 1. To evaluate the analgesic/pain relieving effect of Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg tablet in patients with moderate to severe primary dysmenorrhea.(2. To assess the tolerability profile of the treatment)