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OpenTrials
Completed

NCT Number: NCT00994851

Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.

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.

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Key information

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: No

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

Inclusion criteria

  • Chronic functional constipation present, diagnosed by Rome III criteria.
  • Present in most evacuations intestinal feces classified as Type 1 or 2 by the classification of Bristol.
  • Women sexually active and reproductive age, using more than three months effective contraceptive method.
  • Concordance, level of education and consciousness enough to cooperate with the completion of all study procedures.
  • No contraindication to the use of medication in the study.
  • Availability to attend all the visits of the study evaluation.

Exclusion criteria

  • History or presence of neurological disorders and / or metabolism.
  • Persons with constipation caused by previous surgery.
  • Presence of obstructive lesions in the gastrointestinal tract, including colorectal cancer.
  • Irritable bowel syndrome or inflammatory bowel disease.
  • Multiple Sclerosis
  • Parkinson's disease
  • Other abnormalities such as Hirschsprung's disease and Defecation Dissinrgica.
  • Heart disease and / or hypertension.
  • Continuous use of medication such as analgesics, anti-cholinergic (anti-histamines, antispasmodics, antidepressants, anti-psychotics), supplements with iron or aluminum, Opiates, Anti-hypertensive, CALCIUM CHANNEL BLOCKERS Preganglionic and blockers.
  • Use of any other except the laxative rescue medication during the study.
  • Subjects who do not confirm the diagnosis of ICFC during Phase I of the study.
  • Pregnant or breast-feeding period.
  • Laboratory tests outside the normal range, or the result is assessed as clinically significant by the Investigator.
  • Body Mass Index (BMI) over 30.
  • Participation in another clinical study within 30 days.
  • Do not fill the correct Diary
  • Any condition that in view of the researcher impossible the Subject to participate in the study.

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

Drug

Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day

Placebo

Drug

Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day

Primary outcomes

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

    Time frame: 30 and 45 days

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

    Time frame: 30 and 45 days

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

    Time frame: 30 and 45 days

Secondary outcomes

  1. Number of days without evacuation

    Time frame: 30 days

  2. Proportion of evacuation with pain

    Time frame: 30 days

  3. Proportion of evacuation with strain

    Time frame: 30 days

  4. Proportion of evacuation with incomplete sensation

    Time frame: 30 days

  5. Proportion of blocked stools

    Time frame: 30 days

  6. Proportion of manual maneuvers to facilitate defecation

    Time frame: 30 days

  7. Proportion of subjects that adhere to the diet recommended

    Time frame: 30 days

  8. Proportion of the patients who have to use rescue medication

    Time frame: 30 days

  9. Level of constipation improvement, according to the patient evaluation

    Time frame: 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
2009
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2009
Registry last updated
Mar 29, 2013

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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