An Open-label Study of AJG555 in 1-year-old Patients with Chronic Constipatio
Phase 3
Recruiting
- Conditions
- Chronic constipation
- Registration Number
- JPRN-jRCT2031230142
- Lead Sponsor
- Takeuchi Yutaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
1. Japanese patients with chronic constipation
2. Patients whose number of spontaneous bowel movements was twice a week or less on average for at least
1 month before obtaining informed consent
3. Age: 1 year (when informed consent is obtained)
Exclusion Criteria
1. Patients with known or suspected organic constipation
2. Patients with megacolon and patients with encopresis
3. Patients with known or suspected slow intestinal transit time constipation, including symptomatic
constipation and drug-induced constipation
4. Patients with known or suspected constipation due to defecation disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of the number of spontaneous bowel movements in Week 2 of the treatment period from Week 2 of the pre-treatment observation period
- Secondary Outcome Measures
Name Time Method