General Clinical Study of AJG555 in Pediatric Patients with Chronic Constipatio

Phase 3

Completed

• Conditions: Chronic constipation

• Registration Number: JPRN-jRCT2080223327
• Lead Sponsor: EA Pharma Co.,Ltd.

Brief Summary

To pediatric patients with chronic constipation, AJG555 was administered orally for 12 weeks starting with 1 or 2 sachets once daily according to age, then adjusting the dose based on the patient's status . The change in SBM frequency from Screening Period Week 2 to Treatment Period Week 2 was significantly increased. In addition, constipation-related improvements by AJG555 appeared torough 12 weeks. AJG555 administered for 12 weeks was considered tolerable.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-25
• Study Completion: 2017-06-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

-Patients with chronic constipation

Exclusion Criteria

- Patients with organic constipation or patients suspected of having organic constipation
- Patients with symptomatic constipation or patients suspected of having symptomatic constipation
- Patients with drug-induced constipation or patients suspected of having drug-induced constipation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Frequency of Spontaneous Bowel Movement(SBM) <br>Change from baseline

Secondary Outcome Measures

Name	Time	Method
efficacy<br>safety<br>- Complete Spontaneous Bowel Movement (CSBM)<br>- SBM and CSBM Responder Rate<br>- Number of Dates to the First SBM and First CSBM<br>- Use of Rescue Medication<br>- Stool Consistency Measured by Bristol Stool Form Scale