Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation (ACCESS)

Albireo

Status and phase: Completed; Phase 2

Conditions: Chronic Constipation; Constipation

Treatments: Drug: A3309

Study type: Interventional

Funder types: Industry

Identifiers

NCT01007123

A3309-002

Details and patient eligibility

About

The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.

Enrollment: 190 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient meets protocol specified criteria for constipation
• Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable

Exclusion criteria

• Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
• Patient reports loose stools
• Patient has IBS with pain/discomfort as predominant symptom
• Patient needs medications prohibited as specified in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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190 participants in 4 patient groups, including a placebo group

A3309 low dose

Experimental group

Description:

Administered once daily for the duration of the study

Treatment:

Drug: A3309

A3309 intermediate dose

Experimental group

Description:

Administered once daily for the duration of the study.

Treatment:

Drug: A3309

A3309 high dose

Experimental group

Description:

Administered once daily for the duration of the study

Treatment:

Drug: A3309

Placebo

Placebo Comparator group

Description:

Administered once daily for the duration of the study

Treatment:

Drug: A3309