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

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

29

The proportion of male and female patients was 16 males (55.2%) and 13 females (44.8%), respectively. The mean age (SD) at the time of informed consent was 1.471 (0.273) years and the mean height (SD) at the time of informed consent was 78.43 (4.61) cm. The mean body weight (SD) at baseline was 10.21 (1.42) kg.

All 76 patients who gave consent were provisionally enrolled. Of 76 provisionally enrolled patients, 9 discontinued the study before enrollment, and 38 were ineligible for enrollment. Thus, 29 patients were enrolled. All 29 enrolled patients received the investigational product, and all completed administration of the investigational product.

Adverse events occurred in 82.8% (24/29) of patients. Adverse events that occurred in >= 2 patients were "nasopharyngitis" in 37.9% (11/29 patients), "upper respiratory tract infection" in 17.2% (5/29 patients), "gastroenteritis" in 13.8% (4/29 patients), "adenovirus infection" and "pyrexia" in 10.3% (3/29 patients) each, and "conjunctivitis," "hand-foot-and-mouth disease," "influenza," "otitis media," and "vomiting" in 6.9% (2/29 patients) each. Adverse events related to the investigational product occurred in 6.9% (2/29 patients). These events were "dyspepsia" and "hand dermatitis" in 3.4% (1/29 patients) each, and no adverse events related to the study drug occurred in >= 2 patients.

The mean (SD) spontaneous bowel movement (SBM) frequency was 1.14 (0.79) times in Observation Period Week 2, which increased to 5.76 (2.97) times in Treatment Period Week 2. The mean (SD) change in SBM frequency from Observation Period Week 2 to Treatment Period Week 2 was 4.62 (3.23) times, with a 95% CI of 3.39 to 5.85. The change in SBM frequency was statistically significant in a paired t-test, assuming the null hypothesis of a change of 1 SBM (p < 0.0001). The increase in SBM frequency was maintained through Week 12 of Treatment Period.

AJG555 demonstrated efficacy and an acceptable safety profile in one-year-old patients with chronic constipation.

Feb. 07, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230142

Saito Chihiro

EA Pharma Co., Ltd

2-1-1, Irifune, Chuo-ku, Tokyo

contact_ea@eapharma.co.jp

Saito Chihiro

EA Pharma Co., Ltd

2-1-1, Irifune, Chuo-ku, Tokyo

+81-3-6280-9600

contact_ea@eapharma.co.jp

Complete

July. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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)

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

Both

Chronic constipation

AJG555 is administered orally 1 to 2 sachets daily for 12 weeks.

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

June. 15, 2023

none