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General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

NCT ID: NCT02961556

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-15

Study Completion Date

2017-08-04

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Constipation

Keywords

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AJG555 Constipation Phase 3 Pediatric participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AJG555

After 2 weeks of the screening period, participants will be administered AJG555 starting on the day of the formal enrollment and continuing for 12 weeks.

Group Type EXPERIMENTAL

AJG555

Intervention Type DRUG

Participants will receive 1 to 6 sachets daily per participants' age and conditions.

Interventions

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AJG555

Participants will receive 1 to 6 sachets daily per participants' age and conditions.

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EA Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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EA Pharma Trial Site #1

Yokohama, Kanagawa, Japan

Site Status

EA Pharma Trial Site #2

Yokohama, Kanagawa, Japan

Site Status

EA Pharma Trial Site #1

Bunkyo, Tokyo, Japan

Site Status

EA Pharma Trial Site #1

Hutyu, Tokyo, Japan

Site Status

EA Pharma Trial Site #1

Ōta-ku, Tokyo, Japan

Site Status

EA Pharma Trial Site #1

Setagaya City, Tokyo, Japan

Site Status

EA Pharma Trial Site #2

Setagaya City, Tokyo, Japan

Site Status

EA Pharma Trial Site #1

Shinjuku, Tokyo, Japan

Site Status

EA Pharma Trial Site #2

Shinjuku, Tokyo, Japan

Site Status

EA Pharma Trial Site #1

Hiroshima, , Japan

Site Status

EA Pharma Trial Site #1

Saitama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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AJG555/CT2

Identifier Type: -

Identifier Source: org_study_id