DRUG
linaclotide
oral
Status
Completed
Phase
Phase 2
Enrollment
559
Locations
4
Results
Not posted
Publications
0
Study summary
This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.
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.
Interventions
DRUG
oral
DRUG
oral
Timeline
First posted
Oct 26, 2012
Study start
Aug 10, 2012
Primary completion
Dec 7, 2013
Study completion
Dec 7, 2013
Results posted
Not reported
Registry updated
Oct 18, 2024
Outcomes
Global assessment of relief of IBS symptoms Responder
Time frame · Weekly for 12 weeks
SBM (Spontaneous Bowel Movement) Responder
Time frame · Weekly for 12 weeks
CSBM (Complete SBM) Responder
Time frame · Weekly for 12 weeks
Abnormal bowel habits improvement Responder
Time frame · Weekly for 12 weeks
Abdominal pain/discomfort relief Responder
Time frame · Weekly for 12 weeks
Changes in weekly average of SBM frequency
Time frame · Weekly for 12 weeks
Changes in weekly average of CSBM frequency
Time frame · Weekly for 12 weeks
Changes in weekly average of stool form scores
Time frame · Weekly for 12 weeks
Changes in weekly average of abdominal pain/discomfort severity
Time frame · Weekly for 12 weeks
Changes in weekly average of straining severity
Time frame · Weekly for 12 weeks
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
Time frame · Weekly for 12 weeks
Eligibility
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
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Hokkaido, Japan
Facility not named
Kansai, Japan
Facility not named
Kantou, Japan
Facility not named
Kyusyu, Japan
Publications
No PMID-linked publications were present in this registry snapshot.
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