Clinical trial NCT01714843: A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
Official title: Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Constipation-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation-predominant Irritable Bowel Syndrome (IBS-C)
Keywords: irritable bowel syndrome (IBS)
linaclotide
constipation
ASP0456
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 559
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Global assessment of relief of IBS symptoms Responder
timeFrame: Weekly for 12 weeks
Secondary outcomes:
measure: SBM (Spontaneous Bowel Movement) Responder
timeFrame: Weekly for 12 weeks
measure: CSBM (Complete SBM) Responder
timeFrame: Weekly for 12 weeks
measure: Abnormal bowel habits improvement Responder
timeFrame: Weekly for 12 weeks
measure: Abdominal pain/discomfort relief Responder
timeFrame: Weekly for 12 weeks
measure: Changes in weekly average of SBM frequency
timeFrame: Weekly for 12 weeks
measure: Changes in weekly average of CSBM frequency
timeFrame: Weekly for 12 weeks
measure: Changes in weekly average of stool form scores
timeFrame: Weekly for 12 weeks
measure: Changes in weekly average of abdominal pain/discomfort severity
timeFrame: Weekly for 12 weeks
measure: Changes in weekly average of straining severity
timeFrame: Weekly for 12 weeks
measure: Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
timeFrame: Weekly for 12 weeks
measure: Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs
timeFrame: for 12 weeks
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: