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Clinical Trials/EUCTR2018-001914-13-BE
EUCTR2018-001914-13-BE
Active, not recruiting
Phase 1

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

Salsarulo Pharma0 sites30 target enrollmentAugust 1, 2018
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ConditionsFunctional constipationMedDRA version: 20.0 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Functional constipation
Sponsor
Salsarulo Pharma
Enrollment
30
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Salsarulo Pharma

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Not specified

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