Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-20 @ 12:36 PM
Study NCT ID:
NCT00994851
Status:
COMPLETED
Last Update Posted:
2013-03-29
First Post:
2009-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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.
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: