Skip to main content
OpenTrials
Completed

NCT Number: NCT02961556

General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Constipation Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

EA Pharma Trial Site #1, Yokohama, Kanagawa, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AJG555

Drug

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

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

    Time frame: Screening; Week 2 of administration period

Secondary outcomes

  1. Change from the second week of the screening period in the number of SBMs at each week of the administration period

    Time frame: Screening; up to Week 12 of administration period

  2. Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period

    Time frame: Screening; up to Week 12 of administration period

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

    Time frame: Screening; Week 2

  4. Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration

    Time frame: Screening; Week 2 of administration period

  5. Number of days until SBM and CSBM

    Time frame: up to Week 12 of administration period

  6. Change from the second week of the screening period in the total number of SBMs at each week of the administration period

    Time frame: Screening; up to Week 12 of administration period

  7. Percentage of responders for SBM and CSBM at each week of the administration period

    Time frame: up to Week 12 of administration period

  8. Stool consistency measured by the Bristol stool form scale

    Time frame: up to Week 12 of administration period

  9. Usage of rescue medication

    Time frame: up to Week 12 of administration period

  10. Number of pouches of AJG555 administered

    Time frame: up to Week 12 of administration period

  11. Duration of administration of AJG555

    Time frame: up to Week 12 of administration period

Sponsors and collaborators

Lead sponsor

EA Pharma Co., Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2016
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.