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Completed

NCT Number: NCT00931853

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SENNA+CASSIA(Naturetti)

Drug

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

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)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 2, 2009
Registry last updated
Oct 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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