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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02316899
Other study ID # 0456-CL-0031
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT05643534 - Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years Phase 3
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Completed NCT02495623 - A Study of the Effect of SYN-010 on Subjects With IBS-C Phase 2
Completed NCT01880424 - A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C) Phase 3
Completed NCT02078323 - Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients N/A
Enrolling by invitation NCT05905926 - Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C Phase 3