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CompletedNCT00931853Updated Oct 17, 2012

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

A Phase 3 interventional study of SENNA+CASSIA(Naturetti) in Constipation, sponsored by Sanofi. Completed at 1 site in Brazil. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-17.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
117
Allocation
Non-randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Constipation
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 117 is above the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
117 participants (actual)

Study arms

  • Experimental
    SENNA + CASSIA (Naturetti)

    Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days

    Drug: SENNA+CASSIA(Naturetti)

Interventions

  • DrugSENNA+CASSIA(Naturetti)

    Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days

06

What researchers measure

Primary outcomes

  1. Measure of the chronic functional constipation symptoms based on the Rome III criteria

    Time frame: From the baseline to the end of the study (at 30 days)

Secondary outcomes

  1. Evaluation of the stool aspect based on the Bristol Stool Scale

    Time frame: From the baseline to the end of the study (at 30 days)

  2. Evaluation of the use of sene extract as rescue medication

    Time frame: From the baseline to the end of the study (at 30 days)

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Sao Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00931853
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Jul 2, 2009
Start date
Sep 2010
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Oct 17, 2012

Study contacts

Jaderson Lima
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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