Study of A3309 in Patients With Chronic Idiopathic Constipation - Full Text View

Sponsor:	Albireo
Information provided by (Responsible Party):	Albireo
ClinicalTrials.gov Identifier:	NCT01007123

Purpose

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

Condition	Intervention	Phase
Constipation Chronic Constipation	Drug: A3309	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of A3309 in Patients With Chronic Idiopathic Constipation

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Constipation

U.S. FDA Resources

Further study details as provided by Albireo:

Primary Outcome Measures:

Change from baseline in frequency of spontaneous bowel movements [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Responder analyses for complete spontaneous bowel movements [ Time Frame: weekly and for duration of study ] [ Designated as safety issue: No ]
Time to first bowel movement [ Time Frame: First week ] [ Designated as safety issue: No ]

Enrollment:	190
Study Start Date:	November 2009
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A3309 low dose Administered once daily for the duration of the study	Drug: A3309 A3309 in three different dosage levels or placebo once daily for the duration of the study
Experimental: A3309 intermediate dose Administered once daily for the duration of the study.	Drug: A3309 A3309 in three different dosage levels or placebo once daily for the duration of the study
Experimental: A3309 high dose Administered once daily for the duration of the study	Drug: A3309 A3309 in three different dosage levels or placebo once daily for the duration of the study
Placebo Comparator: Placebo Administered once daily for the duration of the study	Drug: A3309 A3309 in three different dosage levels or placebo once daily for the duration of the study

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007123

Sponsors and Collaborators

Albireo

Investigators

Study Chair:

Hans Graffner, MD

Albireo

More Information

No publications provided

Responsible Party:	Albireo
ClinicalTrials.gov Identifier:	NCT01007123 History of Changes
Other Study ID Numbers:	A3309-002
Study First Received:	November 2, 2009
Last Updated:	January 19, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Albireo:

Chronic idiopathic constipation
A3309

Additional relevant MeSH terms:

Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012