Phase 3 study of AJG555 in patients with chronic constipatio
Phase 3
Completed
- Conditions
- Chronic constipation
- Registration Number
- JPRN-jRCT2080223112
- Lead Sponsor
- EA Pharma Co., Ltd.
- Brief Summary
Treatment with AJG555 was initiated at 2 sachets once a day in patients with chronic constipation for both the 2-wk Confirmatory phase and 52-wk Extension phase. Based on their bowel condition, the dose was adjusted in accordance with the Dose Adjustment Criteria. As a result, the superiority of AJG555 versus the placebo was demonstrated. Moreover, the efficacy of AJG555 lasted for the entire 52-wk Extension phase. the tolerability of AJG555 in patients with chronic constipation was considered acceptable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 156
Inclusion Criteria
Patients with chronic constipation
Exclusion Criteria
Patients with known or suspected organic constipation
Patients with known or suspected symptomatic constipation or drug-induced constipation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>Frequency of Spontaneous Bowel Movement<br>Change from baseline
- Secondary Outcome Measures
Name Time Method efficacy<br>Complete Spontaneous Bowel Movement<br>SBM and CSBM Responder Rate<br>Number of Dates to the First SBM<br>Use of Rescue Medication<br>Stool Consistency Measured by Bristol Stool Form Scale