A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome - Full Text View

Purpose

This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.

Condition	Intervention	Phase
Constipation-predominant Irritable Bowel Syndrome (IBS-C)	Drug: ASP0456 Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Constipation-predominant Irritable Bowel Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Constipation

Drug Information available for: Linaclotide

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Global assessment of relief of IBS symptoms Responder [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SBM (Spontaneous Bowel Movement) Responder [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
CSBM (Complete SBM) Responder [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
Abnormal bowel habits improvement Responder [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
Abdominal pain/discomfort relief Responder [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
Changes in weekly average of SBM frequency [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
Changes in weekly average of CSBM frequency [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
Changes in weekly average of stool form scores [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
Changes in weekly average of abdominal pain/discomfort severity [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
Changes in weekly average of straining severity [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales) [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs [ Time Frame: for 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	525
Study Start Date:	August 2012
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ASP0456 lowest dose group	Drug: ASP0456 oral Other Name: linaclotide
Experimental: ASP0456 low dose group	Drug: ASP0456 oral Other Name: linaclotide
Experimental: ASP0456 middle dose group	Drug: ASP0456 oral Other Name: linaclotide
Experimental: ASP0456 high dose group	Drug: ASP0456 oral Other Name: linaclotide
Placebo Comparator: placebo group	Drug: placebo oral

Detailed Description:

This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after oral administration of ASP0456.

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who had abdominal pain or discomfort repeatedly for at least 3 days per month during the 3 months before screening examination associated with at least 2 out of the following 3 conditions: (1) Improvement with defecation; (2) Onset associated with a change in frequency of stool; and (3) Onset associated with a change in form (appearance) of stool, and had the above symptom (IBS symptom) 6 months or more before the screening examination period.
Patients with ≥25% of stools hard or lumpy (with each bowel movement occurring without antidiarrheal, laxative, suppository or enema) and <25% of them loose (mushy) or watery during the 3 months before the screening examination.
Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of IBS symptom and had no organic changes.

Exclusion Criteria:

Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
Patients with other concurrent diseases that may affect the digestive tract passage or large intestinal function
Patients with other concurrent diseases that may affect the assessment of abdominal pain/discomfort
Patients with blood pressure, pulse rate, clinical laboratory test, or 12-lead ECG at the time of screening examination that was rated as Grade 2 or greater on the "Severity Criteria for Drug Adverse Reaction" and judged to be clinically significant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714843

Contacts

Contact: Clinical Development Administration Dept.

clinicaltrials_info@jp.astellas.com

Locations

Japan
	Recruiting
Hokkaido, Japan
	Recruiting
Kansai, Japan
	Recruiting
Kantou, Japan
	Recruiting
Kyusyu, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Medical Director

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01714843 History of Changes
Other Study ID Numbers:	0456-CL-0021
Study First Received:	October 22, 2012
Last Updated:	November 5, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

ASP0456
constipation
irritable bowel syndrome (IBS)
linaclotide

Additional relevant MeSH terms:

Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional

Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013