MedTrace Logo

Long-term Elobixibat for Chronic Constipation

NCT04784780 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-01-05

No results posted yet for this study

Summary

In this double-blind comparative study, AJG533 (elobixibat) 10 mg or AJG533 placebo was orally administered once daily before meals for 12 weeks in patients with chronic constipation, and the primary endpoint was the change from Week 2 of the observation period in the number of complete spontaneous bowel movements (CSBM) at Week 12 of the treatment period. The primary endpoint was the change in the number of complete spontaneous bowel movements (CSBM) from Week 2 of the observation period.

Conditions

  • Chronic Constipation

Interventions

DRUG

Elobixibat 10mg

Patients with chronic constipation are administered Elobixibat 10mg for 12 weeks

DRUG

Placebo

Patients with chronic constipation are administered placebo for 12 weeks

Sponsors & Collaborators

  • Yokohama City University

    lead OTHER

Principal Investigators

  • Takaomi Kessoku, M.D., PhD. · Yokohama City University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2023-06-30
Completion
2023-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04784780 on ClinicalTrials.gov