Clinical trial NCT02961556: General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
Official title: General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Constipation
Keywords: AJG555
Constipation
Phase 3
Pediatric participants
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 39
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Screening; Week 2 of administration period
Secondary outcomes:
measure: Change from the second week of the screening period in the number of SBMs at each week of the administration period
timeFrame: Screening; up to Week 12 of administration period
measure: Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period
timeFrame: Screening; up to Week 12 of administration period
measure: Change from the screening period in the number of SBMs at two weeks after the initiation of the administration
timeFrame: Screening; Week 2
measure: Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration
timeFrame: Screening; Week 2 of administration period
measure: Number of days until SBM and CSBM
timeFrame: up to Week 12 of administration period
measure: Change from the second week of the screening period in the total number of SBMs at each week of the administration period
timeFrame: Screening; up to Week 12 of administration period
measure: Percentage of responders for SBM and CSBM at each week of the administration period
timeFrame: up to Week 12 of administration period
measure: Stool consistency measured by the Bristol stool form scale
timeFrame: up to Week 12 of administration period
measure: Usage of rescue medication
timeFrame: up to Week 12 of administration period
measure: Number of pouches of AJG555 administered
timeFrame: up to Week 12 of administration period
measure: Duration of administration of AJG555
timeFrame: up to Week 12 of administration period
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: EA Pharma Trial Site #1
state: Kanagawa
city: Yokohama
country: Japan
facility: EA Pharma Trial Site #2
state: Kanagawa
city: Bunkyo
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Hutyu
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Setagaya
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Setagaya
country: Japan
facility: EA Pharma Trial Site #2
state: Tokyo
city: Shinjuku
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Shinjuku
country: Japan
facility: EA Pharma Trial Site #2
state: Tokyo
city: Ōta
country: Japan
facility: EA Pharma Trial Site #1
state: Tokyo
city: Hiroshima
country: Japan
facility: EA Pharma Trial Site #1
city: Saitama
country: Japan
facility: EA Pharma Trial Site #1
Study officials:
References: