General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961556
• Other study ID #: AJG555/CT2
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2016
• Last updated: October 20, 2017
• Start date: November 15, 2016
• Est. completion date: August 4, 2017

Study information

• Verified date: October 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation. The safety and efficacy of 12 weeks of administration will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 4, 2017
• Est. primary completion date: June 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

Inclusion Criteria:

Main Inclusion Criteria:

• Participants with chronic constipation

• Age: 2 years old or older and 14 years old or younger (at the time of the informed consent)

• Gender: N/A

Exclusion Criteria:

Main Exclusion Criteria:

• Participants with organic constipation or participants suspected of having organic constipation

• Participants with symptomatic constipation or participants suspected of having symptomatic constipation

• Participants with drug-induced constipation or participants suspected of having drug-induced constipation

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• AJG555
Participants will receive 1 to 6 sachets daily per participants' age and conditions.

Locations

Country	Name	City	State
Japan	EA Pharma Trial Site #1	Bunkyo	Tokyo
Japan	EA Pharma Trial Site #1	Hiroshima
Japan	EA Pharma Trial Site #1	Hutyu	Tokyo
Japan	EA Pharma Trial Site #1	Ota	Tokyo
Japan	EA Pharma Trial Site #1	Saitama
Japan	EA Pharma Trial Site #1	Setagaya	Tokyo
Japan	EA Pharma Trial Site #2	Setagaya	Tokyo
Japan	EA Pharma Trial Site #1	Shinjuku	Tokyo
Japan	EA Pharma Trial Site #2	Shinjuku	Tokyo
Japan	EA Pharma Trial Site #1	Yokohama	Kanagawa
Japan	EA Pharma Trial Site #2	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
EA Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the second week of the screening period in the number of spontaneous bowel movements (SBMs) at the second week of the administration period		Screening; Week 2 of administration period
Secondary	Change from the second week of the screening period in the number of SBMs at each week of the administration period		Screening; up to Week 12 of administration period
Secondary	Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period		Screening; up to Week 12 of administration period
Secondary	Change from the screening period in the number of SBMs at two weeks after the initiation of the administration		Screening; Week 2
Secondary	Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration		Screening; Week 2 of administration period
Secondary	Number of days until SBM and CSBM		up to Week 12 of administration period
Secondary	Change from the second week of the screening period in the total number of SBMs at each week of the administration period		Screening; up to Week 12 of administration period
Secondary	Percentage of responders for SBM and CSBM at each week of the administration period		up to Week 12 of administration period
Secondary	Stool consistency measured by the Bristol stool form scale		up to Week 12 of administration period
Secondary	Usage of rescue medication		up to Week 12 of administration period
Secondary	Number of pouches of AJG555 administered		up to Week 12 of administration period
Secondary	Duration of administration of AJG555		up to Week 12 of administration period