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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01714843
First received: October 22, 2012
Last updated: April 29, 2014
Last verified: April 2014
  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:


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 ]

Enrollment: 559
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
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: April 29, 2014
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
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 24, 2014