CTRI/2020/08/027248已完成2 期
A randomized double-blind, placebo-controlled, multi center, parallel group pilot study of the safety and efficacy of hydrocortisone acetate suppositories, 25 mg compared to placebo suppositories in the treatment of symptomatic internal hemorrhoids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- The objective of this study is;
研究概览
简要总结
The study is a randomized, double-blind,placebo-controlled, multicenter, parallel group study of the safety and efficacyof Hydrocortisone Acetate Suppositories, in the treatment of internalhemorrhoids. Hydrocortisone is thought to improve the disease condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Have a diagnosis of internal hemorrhoids.
- •Is a male or female aged 18 years and older c.
- •Give voluntary consent to participate in the study following a full explanation of the nature and purpose of the study, by signing the IRB-approved Informed Consent document prior to any study specific evaluations.
- •Is willing to forego the use of non-prescription (OTC) and prescription medication or procedures for the treatment of hemorrhoidal disease and/or pain for the duration of the study.
- •Female Subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized (by hysterectomy) or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
- •Subjects on hormonal contraception must be stabilized on the same type prior to enrollment in the study and must not change the method during the study.
- •All male Subjects must agree to use accepted methods of birth control with their partners.
- •Female partners should use an acceptable method of birth control as described in the above Item.
排除标准
- •Has inflammatory bowel disease.
- •Is immunocompromised (e.g. receiving cancer chemotherapy, steroids, HIV positive).
- •Is a pregnant or nursing female.
- •Subjects who have unstable medical disorders that are clinically significant or have life-threatening diseases.
- •Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates).
- •Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an investigational drug) Lacks suitability for participation in this study for any reason in the opinion of the Investigator.
- •Clinically significant complete blood count (CBC), comprehensive metabolic panel (CMP), urinalysis or positive HIV, Hepatitis B, Hepatitis C.
结局指标
主要结局
The objective of this study is;
时间窗: Beginning of the study at Baseline and at the End of study which is considered as Week-4
1.To determine the effectiveness of Nivagen’s Hydrocortisone Acetate Suppositories in internal hemorrhoids.
时间窗: Beginning of the study at Baseline and at the End of study which is considered as Week-4
2. To determine the safety and tolerability of Nivagen’s Hydrocortisone Acetate Suppositories
时间窗: Beginning of the study at Baseline and at the End of study which is considered as Week-4
次要结局
- Not Applicable(Not Applicable)
研究者
研究点 (9)
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