Tolerability Study of MHS 1031 for Chronic Idiopathic Constipation

Unknown Not Applicable NCT05129618

Study Description

This is a double-blind, placebo-controlled trial to assess the tolerability of MHS 1031 for Chronic Idiopathic Constipation (CIC). The study consists of 3 distinct periods where subjects will receive either MHS 1031 or a placebo for 8 weeks, followed by an open-label period where all subjects will be taking MHS 1031, and 2 weeks of follow-up phase. The assessment of tolerability will be conducted using the change in bowel movement frequency, patient-reported outcomes, concomitant medication assessments, and adverse events. Tolerability is defined as no overall worsening of constipation measurement scores after 8 weeks of taking the product or the placebo compared to baseline scores.

Study Details

Registry ID:
NCT05129618
Conditions:
Constipation Chronic Idiopathic
Phase:
Not Applicable
Target Enrollment:
172 participants
Start Date:
Age Range:
18–75 years
Healthy Volunteers:
No

Study Locations (1 site)

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