Efficacy and Tolerability of Cassia Fistula Plus Senna Al... | NCT00931853

Studies
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).

NCT00931853

Sponsor

Sanofi

Status

Completed

Last Update Posted

Oct 17, 2012Estimated

Enrollment

117Actual

Phase

Phase 3

Conditions

Constipation

Interventions

SENNA+CASSIA(Naturetti)

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jul 1, 2009

First Submission Date that Met QC Criteria

Jul 1, 2009

First Posted Date

Jul 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2012

Last Update Posted Date

Oct 17, 2012Estimated

Description Module

Brief Summary

Primary Objective:

To evaluate the clinical efficacy of Naturetti (jelly sugar free)
To test medication on subjects who suffer chronic functional constipation in 30 days use.

Secondary Objectives:

To demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. The components will be evaluated by the adverse events occurrence classified by possibly related, probably related and definitely related
To demonstrate the clinical tolerability of the study medication by the continuous use during the second phase study
To identify any adverse events related to the study drug
To identify any drug interaction.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SENNA + CASSIA (Naturetti)	Experimental	Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days	Drug: SENNA+CASSIA(Naturetti)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SENNA+CASSIA(Naturetti)	Drug	Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days	SENNA + CASSIA (Naturetti)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of the chronic functional constipation symptoms based on the Rome III criteria		From the baseline to the end of the study (at 30 days)

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the stool aspect based on the Bristol Stool Scale		From the baseline to the end of the study (at 30 days)
Evaluation of the use of sene extract as rescue medication		From the baseline to the end of the study (at 30 days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Having chronic functional constipation by ROME IIII criteria
Having the majority of the stool as type 1 or 2 by Bristol Stool Scale
Female subjects should be using an effective contraceptive method more than 3 months if they are sexually active and on reproductive stage
ICF signature
Be able to understand and agree to undertake the study procedures
Having no contraindication related to the study drug
To perform all study visits.

Exclusion criteria:

Having previous history or current neurological disorder and/or metabolic one
Having constipation caused by previous surgery
Having intestinal obstruction including colon/rectum cancer
Having endocrine disorder as diabetes mellitus
Having Irritable bowel syndrome or inflammatory bowel disease
Having multiple sclerosis
Having Parkinsons disease
Having Hirschsprungs disease and dyssynergy defecation
Continuous treatment with the following: analgesics, anticholinergic (antihistamines, antispasmodics, antidepressants, antipsychotics) iron supplements or aluminum, opiates, antihypertensive, calcium channel blockers and ganglionic blocker
Treatment with any other laxative medication other than the rescue medication during the study
Patients who could not confirm the chronic functional constipation during the phase I study
Pregnancy or breast feeding woman
Abnormal laboratory results, or clinical result that shows significant by the Investigator
Corporeal mass index > 30
Patients who have participate in other clinical study within 30 days
Unable to fulfill the questionnaire (diary)
Any condition that makes impossible to the patient in participates by Investigator opinion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms