NCT02961556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

November 15, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

November 9, 2016

Last Update Submit

October 20, 2017

Conditions

Chronic Constipation

Keywords

AJG555ConstipationPhase 3Pediatric participants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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

  • 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

  • Change from the screening period in the number of SBMs at two weeks after the initiation of the administration

    Screening; Week 2

  • 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

  • Number of days until SBM and CSBM

    up to Week 12 of administration period

  • +6 more secondary outcomes

Study Arms (1)

AJG555

EXPERIMENTAL

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.

Drug: AJG555

Interventions

AJG555DRUG

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

AJG555

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

EA Pharma Trial Site #1

Yokohama, Kanagawa, Japan

Location

EA Pharma Trial Site #2

Yokohama, Kanagawa, Japan

Location

EA Pharma Trial Site #1

Bunkyo, Tokyo, Japan

Location

EA Pharma Trial Site #1

Hutyu, Tokyo, Japan

Location

EA Pharma Trial Site #1

Ōta-ku, Tokyo, Japan

Location

EA Pharma Trial Site #1

Setagaya City, Tokyo, Japan

Location

EA Pharma Trial Site #2

Setagaya City, Tokyo, Japan

Location

EA Pharma Trial Site #1

Shinjuku, Tokyo, Japan

Location

EA Pharma Trial Site #2

Shinjuku, Tokyo, Japan

Location

EA Pharma Trial Site #1

Hiroshima, Japan

Location

EA Pharma Trial Site #1

Saitama, Japan

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 11, 2016

Study Start

November 15, 2016

Primary Completion

June 9, 2017

Study Completion

August 4, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10

Locations

JP(11)