Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
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)
1 other identifier
interventional
500
1 country
61
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2014
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2014
CompletedFirst Submitted
Initial submission to the registry
December 4, 2014
CompletedFirst Posted
Study publicly available on registry
December 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2016
CompletedOctober 18, 2024
October 1, 2024
11 months
December 4, 2014
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (13)
Responder rate of SBM during 12 weeks
During 12 weeks
Responder rate of Abnormal bowel habits improvement during 12 weeks
During 12 weeks
Responder rate of Abdominal pain/discomfort relief during 12 weeks
During 12 weeks
Weekly responder rate of Global assessment of relief of IBS symptoms
Up to 52 weeks
Weekly responder rate of CSBM
Up to 52 weeks
- +8 more secondary outcomes
Study Arms (3)
ASP0456 (Period I)
EXPERIMENTALUp to 12 weeks
Placebo (Period I)
PLACEBO COMPARATORUp to 12 weeks
ASP0456 (Period II)
EXPERIMENTALFrom 12 weeks to 52 weeks
Interventions
Oral administration once daily
Eligibility Criteria
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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
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
Hyōgo, Japan
Site JP00058
Hyōgo, Japan
Site JP00059
Hyōgo, 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, Japan
Related Publications (1)
Fukudo S, Miwa H, Nakajima A, Haruma K, Kosako M, Nakagawa A, Akiho H, Yamaguchi Y, Johnston JM, Currie M, Kinoshita Y. A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan. Neurogastroenterol Motil. 2018 Dec;30(12):e13444. doi: 10.1111/nmo.13444. Epub 2018 Aug 22.
PMID: 30136447DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
December 4, 2014
First Posted
December 15, 2014
Study Start
October 21, 2014
Primary Completion
September 19, 2015
Study Completion
March 29, 2016
Last Updated
October 18, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.