General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

EA Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Constipation

Treatments: Drug: AJG555

Study type: Interventional

Funder types: Industry

Identifiers

NCT02961556

AJG555/CT2

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

AJG555

Experimental group

Description:

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.

Treatment:

Drug: AJG555