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临床试验/NCT00994851
NCT00994851已完成3 期

National Study, Phase III, Parallel, Double Blind, Placebo Comparative and Randomized to Evaluate the Therapeutic Efficacy and Tolerability of the Combination Naturetti® (Cassia Fistula + Senna Alexandrina Miller) in the Chronic Functional Constipation.

Sanofi1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Sanofi
入组人数
96
试验地点
1
主要终点
Evaluation of the evacuation frequency during the treatment and follow-up period

研究概览

简要总结

Primary Objective:

To evaluate the clinical efficacy of Naturetti (capsules) , considering the following criteria:

  • Evacuation frequency during the treatment and follow-up period
  • Consistency of stools during the treatment and follow-up period
  • Global evaluation, regarding increase in frequency of evacuation and shape of stools.

Secondary Objective:

  • Number of days without evacuation
  • Proportion of evacuation with pain
  • Proportion of evacuation with strain
  • Proportion of evacuation with incomplete sensation
  • Proportion of blocked stools
  • Proportion of manual maneuvers to facilitate defecation
  • Proportion of subjects that adhere to the diet recommended
  • Proportion of the patients who have to use rescue medication
  • Level of constipation improvement, according to the patient evaluation
  • To evaluate clinical tolerability of the study medication by the continuous use
  • To evaluate the occurrence of adverse events related to the study drug
  • To identify any drug interaction.

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 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

SENNA+ CASSIA

Experimental

Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days

干预措施: SENNA+CASSIA (Drug)

Placebo

Placebo Comparator

Daily administration (capsule) of placebo at bedtime, during 30 days

干预措施: placebo (Drug)

结局指标

主要结局

Evaluation of the evacuation frequency during the treatment and follow-up period

时间窗: 30 and 45 days

Evaluation of the stools consistency during the treatment and follow-up period

时间窗: 30 and 45 days

Global evaluation, regarding increase in frequency of evacuation and shape of stools

时间窗: 30 and 45 days

次要结局

  • Number of days without evacuation(30 days)
  • Proportion of evacuation with pain(30 days)
  • Proportion of evacuation with strain(30 days)
  • Proportion of evacuation with incomplete sensation(30 days)
  • Proportion of blocked stools(30 days)
  • Proportion of manual maneuvers to facilitate defecation(30 days)
  • Proportion of subjects that adhere to the diet recommended(30 days)
  • Proportion of the patients who have to use rescue medication(30 days)
  • Level of constipation improvement, according to the patient evaluation(30 days)

研究者

发起方
Sanofi
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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