DRUG
linaclotide
Oral administration once daily
Status
Completed
Phase
Phase 3
Enrollment
186
Locations
39
Results
Not posted
Publications
0
Study summary
The objective of this study is to verify the efficacy and investigate the safety of the study drug when ASP0456 is administered orally for 4 weeks and 52 weeks.
This study consists of two parts. In Part I, ASP0456 or placebo will be administered orally in a blind manner. In Part II, the long-term safety and efficacy of ASP0456 will be evaluated in patients who have participated in the study and completed the Part I.
Interventions
DRUG
Oral administration once daily
DRUG
Oral administration once daily
Timeline
First posted
Jun 22, 2016
Study start
Jun 24, 2016
Primary completion
Nov 14, 2016
Study completion
Nov 10, 2017
Results posted
Not reported
Registry updated
Oct 18, 2024
Outcomes
Change from baseline in weekly mean SBM frequency during one week of administration (Part I)
Time frame · Baseline and Week 1
SBM: Spontaneous bowel movement
Change from baseline in weekly mean SBM frequency
Time frame · Baseline and up to Week 56
Weekly responder rate of SBM
Time frame · Baseline and up to Week 56
The weekly average 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.
Percentage of subjects with SBM within 24 hours after the start of the initial administration
Time frame · Up to 24h
Time to first SBM
Time frame · Up to Week 4
Change from baseline in weekly mean CSBM frequency
Time frame · Baseline and up to Week 56
CSBM: SBM without a sensation of incomplete evacuation
Weekly responder rate of CSBM
Time frame · Baseline and up to Week 56
The weekly average 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.
Percentage of subjects with CSBM within 24 hours after the start of the initial administration
Time frame · Up to 24h
Change from baseline in weekly mean stool form score
Time frame · Baseline and up to Week 56
Stool form will be measured using seven-point Bristol Stool Form Scale.
Change from baseline in weekly mean abdominal bloating severity score
Time frame · Baseline and up to Week 56
Abdominal bloating severity will be measured using a five-point ordinal score.
Change from baseline in weekly mean abdominal pain/discomfort severity score
Time frame · Baseline and up to Week 56
Abdominal pain/discomfort severity will be measured using a five-point ordinal score.
Eligibility
Inclusion Criteria: * Patients with SBM frequency for \< 3 times/week, since ≥ 6 months prior to preliminary enrollment * Patients with one or more related symptoms for ≥ 6 months prior to preliminary enrollment * Patients at whom loose (mushy) or watery stools are rarely present without the use of laxatives for ≥ 6 months prior to preliminary enrollment * Patients who underwent pancolonoscopy or contrast enema after development of the CC symptoms and within 5 years prior to preliminary enrollment, and in whom no organic change was observed which dose not influence on CC symptoms * Female patients must be either: If of non-childbearing potential: * Post-menopausal at the preliminary enrollment, or documented surgically sterile Or, if of childbearing potential, * Agree not to try to become pregnant during the study and for 28 days after the final study drug administration * And have a negative urine pregnancy test at screening * And, if heterosexually active, agree to consistently use two forms of highly effective birth control throughout the study period and for 28 days after the final study drug administration * Female patients must agree not to breastfeed throughout the study period and for 28 days after the final study drug administration * Female patients must not donate ova starting throughout the study period and for 28 days after the final study drug administration * Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control starting at Screening and continue throughout the study period, and for 28 days after the final study drug administration * Male subject must not donate sperm starting at Screening and throughout the study period and, for 28 days after the final study drug administration Exclusion Criteria: * Patients who have met the Rome III diagnostic criteria for IBS; with recurrent abdominal pain or discomfort for ≥ 3 days/month in the last 3 months prior to preliminary enrollment, associated with ≥ 2 of the 3 characteristics described below and with the symptoms (IBS symptoms) described above for ≥ 6 months prior to preliminary enrollment 1. Improvement with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance) of stool * Patients with a history of surgical resection of the stomach, gallbladder, small intestine, or large intestine * Patients with a history or current evidence of inflammatory bowel disease or ischemic colitis * Patients with concurrent infectious enteritis, hyperthyroidism or hypothyroidism, constipation due to anorectal dysfunction, drug-induced constipation, constipation due to other organic diseases or active peptic ulcer * Patients with apparent mechanical obstruction * Patients with megacolon or megarectum * For female patients, patients with concurrent endometriosis or adenomyosis * Patients who are considered to have severe depression or a severe anxiety disorder that can affect the efficacy evaluation of the study drug * Patients with a history of abuse of drugs or alcohol, or current abuse of drugs or alcohol * Patients who used/underwent or are scheduled to use/undergo prohibited concomitant drugs or therapies, or in whom prohibited examinations were conducted or are scheduled to be conducted 3 days prior to the start of the bowel habit observation period * Patients with a history or current evidence of malignant tumors * Patients with concurrent serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal disorders, blood diseases, or neurological/psychiatric diseases * Patients with a history of drug allergies * Patients who have participated in the clinical trial of ASP0456 or have been administered ASP0456 * Patients who have participated or are participating in another clinical trial or post-marketing clinical study of other ethical drugs or medical devices within 12 weeks prior to obtaining informed consent
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Site JP00029
Aichi, Japan
Site JP00030
Aichi, Japan
Site JP00021
Chiba, Japan
Site JP00022
Chiba, Japan
Site JP00023
Chiba, Japan
Site JP00024
Chiba, Japan
Site JP00040
Fukuoka, Japan
Site JP00001
Hokkaido, Japan
Site JP00002
Hokkaido, Japan
Site JP00037
Hyōgo, Japan
Site JP00038
Hyōgo, Japan
Site JP00039
Hyōgo, Japan
Site JP00017
Kanagawa, Japan
Site JP00018
Kanagawa, Japan
Site JP00019
Kanagawa, Japan
Site JP00020
Kanagawa, Japan
Site JP00031
Osaka, Japan
Site JP00032
Osaka, Japan
Site JP00033
Osaka, Japan
Site JP00034
Osaka, Japan
Site JP00035
Osaka, Japan
Site JP00036
Osaka, Japan
Site JP00025
Saitama, Japan
Site JP00026
Saitama, Japan
Publications
No PMID-linked publications were present in this registry snapshot.
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