An Open-label Study of AJG555 in 1-year-old Patients with Chronic Constipation

JRCT ID: jRCT2031230142

Registered date:16/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic constipation
• Date of first enrollment: 22/07/2023
• Target sample size: 26
• Study type: Interventional
• Intervention(s): AJG555 is administered orally 1 to 2 sachets daily for 12 weeks.

Outcome(s)

• Primary Outcome: Change of the number of spontaneous bowel movements in Week 2 of the treatment period from Week 2 of the pre-treatment observation period

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 2age old
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Saito Chihiro