Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial

Official title:

Phase III Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and Long-term Study in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316899
• Other study ID #: 0456-CL-0031
• Status: Completed
• Phase: Phase 3
• Start date: October 21, 2014
• Est. completion date: March 29, 2016

Study information

• Verified date: December 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients with constipation predominant irritable bowel syndrome (IBS-C).

Description:

A multicenter, collaborative, double-blind, parallel comparative study is conducted using IBS-C patients as subjects to verify efficacy of ASP0456 and examine the safety. After the 2-week bowel habit observation period, subjects satisfying the primary enrollment criteria are randomly allocated to either ASP0456 group or placebo group, and orally administered the drug or placebo once daily before breakfast for 12 weeks.

A multicenter, collaborative, non-blind, non-controlled study is conducted to examine safety and efficacy of ASP0456 in long-term administration in IBS-C patients. After Period I, subjects satisfying the transfer criteria are orally administered ASP0456 once daily before breakfast for 40 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 29, 2016
• Est. primary completion date: September 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

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:

• Patient with history of surgical resection of stomach, gallbladder, small intestine, or large intestine (excluding resection of appendicitis and benign polyp)

• Patient with history or current affection of inflammatory bowel disease (Crohn's disease or ulcerative colitis)

• Patient with history or current affection of ischemic colitis

• Patient currently affected by infectious enteritis

• Patient currently affected by hyperthyroidism or hypothyroidism

• Patient currently affected by active peptic ulcer

• In the case of a female patient, the one currently affected by endometriosis or uterine adenomyosis

• Patient with high depression or anxiety considered to influence drug evaluation

• Patient with history of abuse of drug or alcohol within a year before consent acquisition, or with current abuse

• Patient who used or underwent or will use or undergo drug/therapy/test prohibited to combine 3 days before the start of bowel habit observation period (Day -17) or thereafter

• Patient with history or current affection of malignant tumor

• Patient currently affected by serious cardiovascular disease, respiratory disease, kidney disease, hepatic disease, gastrointestinal disease (excluding IBS), hemorrhagic disease, or neural/mental disease

• Patient with history of drug allergy

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation (IBS-C)
• Syndrome

Intervention

Drug:
• linaclotide
Oral administration once daily
• Placebo
Oral administration once daily

Locations

Country	Name	City	State
Japan	Site JP00004	Aichi
Japan	Site JP00048	Aichi
Japan	Site JP00049	Aichi
Japan	Site JP00038	Chiba
Japan	Site JP00039	Chiba
Japan	Site JP00040	Chiba
Japan	Site JP00041	Chiba
Japan	Site JP00042	Chiba
Japan	Site JP00002	Fukuoka
Japan	Site JP00060	Fukuoka
Japan	Site JP00061	Fukuoka
Japan	Site JP00001	Hokkaido
Japan	Site JP00006	Hokkaido
Japan	Site JP00007	Hokkaido
Japan	Site JP00057	Hyogo
Japan	Site JP00058	Hyogo
Japan	Site JP00059	Hyogo
Japan	Site JP00030	Kanagawa
Japan	Site JP00031	Kanagawa
Japan	Site JP00032	Kanagawa
Japan	Site JP00033	Kanagawa
Japan	Site JP00034	Kanagawa
Japan	Site JP00035	Kanagawa
Japan	Site JP00036	Kanagawa
Japan	Site JP00037	Kanagawa
Japan	Site JP00056	Kyoto
Japan	Site JP00003	Osaka
Japan	Site JP00050	Osaka
Japan	Site JP00051	Osaka
Japan	Site JP00052	Osaka
Japan	Site JP00053	Osaka
Japan	Site JP00054	Osaka
Japan	Site JP00055	Osaka
Japan	Site JP00043	Saitama
Japan	Site JP00044	Saitama
Japan	Site JP00045	Saitama
Japan	Site JP00046	Saitama
Japan	Site JP00047	Saitama
Japan	Site JP00005	Tokyo
Japan	Site JP00008	Tokyo
Japan	Site JP00009	Tokyo
Japan	Site JP00010	Tokyo
Japan	Site JP00011	Tokyo
Japan	Site JP00012	Tokyo
Japan	Site JP00013	Tokyo
Japan	Site JP00014	Tokyo
Japan	Site JP00015	Tokyo
Japan	Site JP00016	Tokyo
Japan	Site JP00017	Tokyo
Japan	Site JP00018	Tokyo
Japan	Site JP00019	Tokyo
Japan	Site JP00020	Tokyo
Japan	Site JP00021	Tokyo
Japan	Site JP00022	Tokyo
Japan	Site JP00023	Tokyo
Japan	Site JP00024	Tokyo
Japan	Site JP00025	Tokyo
Japan	Site JP00026	Tokyo
Japan	Site JP00027	Tokyo
Japan	Site JP00028	Tokyo
Japan	Site JP00029	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate of Global assessment of relief of IBS symptoms during 12 weeks.	The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.	During 12 weeks
Primary	Responder rate of CSBM during 12 weeks	CSBM: Complete Spontaneous Bowel Movement. The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.	During 12 weeks
Secondary	Responder rate of SBM during 12 weeks	SBM: Spontaneous Bowel Movement	During 12 weeks
Secondary	Responder rate of Abnormal bowel habits improvement during 12 weeks		During 12 weeks
Secondary	Responder rate of Abdominal pain/discomfort relief during 12 weeks		During 12 weeks
Secondary	Weekly responder rate of Global assessment of relief of IBS symptoms	The weekly responder of the evaluation items shall be the subject satisfying the followings at the time of evaluation in each week.Score of Global assessment of relief of IBS symptoms (7 scores: 1-7) is 1 or 2	Up to 52 weeks
Secondary	Weekly responder rate of CSBM	Weekly responder of CSBM: The weekly mean value of CSBM frequency is more than 3 and over 1 more than the weekly mean value of CSBM frequency in the bowel habit observation period	Up to 52 weeks
Secondary	Weekly responder rate of SBM	Weekly responder of SBM: The weekly mean value of SBM frequency is more than 3 and over 1 more than the weekly mean value of SBM frequency in the bowel habit observation period	Up to 52 weeks
Secondary	Weekly responder rate of Abnormal bowel habits improvement	Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2	Up to 52 weeks
Secondary	Weekly responder rate of Abdominal pain/discomfort relief	Score of abdominal pain/discomfort improvement effect (7 scores: 1-7) is 1 or 2.	Up to 52 weeks
Secondary	Changes in weekly average of SBM frequency, CSBM frequency, stool form scores, abdominal pain/discomfort severity, abdominal bloating severity, and straining severity.		From baseline to every week until 52 weeks
Secondary	Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)	IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version	Weeks 0, 4, 8, 12, 16, 20, 24, 28, 40, 52
Secondary	Percentage of subjects with SBM within 24 hours after start of the initial administration		Up to 24 hours
Secondary	Percentage of subjects with CSBM within 24 hours after start of the initial administration		Up to 24 hours
Secondary	Safety assessed by development of incidence of adverse events, vital signs, and clinical laboratory tests		Up to 52 weeks

External Links

•   Link to results on Astellas Clinical Study Results website