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

NCT01714843 | Completed Phase 2

• 1 other identifier: 0456-CL-0021
• Study Type: interventional
• Target: 559
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Keywords

irritable bowel syndrome (IBS); linaclotide; constipation; ASP0456

Outcome Measures

Primary Outcomes (1)

• Global assessment of relief of IBS symptoms Responder

  Weekly for 12 weeks

Secondary Outcomes (11)

• SBM (Spontaneous Bowel Movement) Responder

  Weekly for 12 weeks

• CSBM (Complete SBM) Responder

  Weekly for 12 weeks

• Abnormal bowel habits improvement Responder

  Weekly for 12 weeks

• Abdominal pain/discomfort relief Responder

  Weekly for 12 weeks

• Changes in weekly average of SBM frequency

  Weekly for 12 weeks

Study Arms (5)

ASP0456 lowest dose group

EXPERIMENTAL

oral

Drug: linaclotide

ASP0456 low dose group

EXPERIMENTAL

oral

Drug: linaclotide

ASP0456 middle dose group

EXPERIMENTAL

oral

Drug: linaclotide

ASP0456 high dose group

EXPERIMENTAL

oral

Drug: linaclotide

placebo group

PLACEBO COMPARATOR

oral

Drug: placebo

Interventions

linaclotide DRUG

oral

Also known as: ASP0456

ASP0456 high dose group; ASP0456 low dose group; ASP0456 lowest dose group; ASP0456 middle dose group

placebo DRUG

oral

placebo group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (4)

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation

Interventions

linaclotide

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 26, 2012
• Study Start: August 10, 2012
• Primary Completion: December 7, 2013
• Study Completion: December 7, 2013
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)