Clinical Trial to Evaluate the Efficacy and Safety of MACRORANGE® in Patients Suffering from Constipatio

Phase 1

• Conditions: Functional constipation; MedDRA version: 20.0 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-001914-13-BE
• Lead Sponsor: Salsarulo Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-01
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• Age of the patients: = 18 years of age;
• Male and female patients;
• Stool frequency < 3 per week;
• Functional constipation as defined in constipation module of ROME III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

• Irritable Bowel Syndrome (IBS specifically type C);
• Hypersensitivity to the active substances or any excipients;
• Organic inflammatory bowel disease (ulcerative rectocolitis, Crohn’s disease);
• Toxic megacolon;
• Gastrointestinal obstruction or subocclusive syndromes;
• Allergic to aspartame;
• Painful abdominal syndromes of undetermined origin;
• Existing partial colectomy or bariatric surgery (gastric bypass type);
• Presumed non-cooperativeness;
• Concomitant treatment from start of wash-out period until discharge from the study with any medication that may alter the gastrointestinal motility (see section 6.2.2) in the opinion of the Investigator;
• Legal incapacity;
• Any clinical condition which does not justify study participation in the Investigator's opinion;
• Participation = 8 weeks in a clinical trial;
• Parallel participation in a clinical trial;
• Repeated participation in this clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of MACRORANGE® in patients with functional constipation (according to Rome III criteria) after daily administration of MACRORANGE® up to 14 days. ;<br> Secondary Objective: To describe the average daily dosage of MACRORANGE® from Day 3 up to End of Study.<br> To further evaluate the tolerance of MACRORANGE® in patients with functional constipation.<br> To evaluate the taste of MACRORANGE®.<br> ;<br> Primary end point(s): After a washout of one week, the primary endpoint will be:<br> • The average number of complete spontaneous defecations per week for a 2 weeks period.<br> ;Timepoint(s) of evaluation of this end point: Everyday during the 2-weeks treatment period (via a patient diary)