Sanofi-Aventis Administrative Office
São Paulo, Brazil
NCT Number: NCT00994851
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.
Looking for future studies?
Notify Me18 year–59 year
All sexes
Interventional
Phase 3
São Paulo, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day
Time frame: 30 and 45 days
Time frame: 30 and 45 days
Time frame: 30 and 45 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Sanofi
Industry
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.
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.
Published trials that share one or more normalized conditions with this study.
NCT04068415
Constipation, Pathological Conditions, Signs and Symptoms
View Trial DetailsNCT04666155
Constipation, Constipation - Functional
Durham, County Durham and Darlington, United Kingdom
View Trial DetailsNCT06311097
Constipation, Healthy
Copenhagen, Denmark
View Trial DetailsNCT07230821
Carbohydrate Metabolism, Inborn Errors, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Del Mar, California, United States
View Trial Details