Current partner codePEPTIDESDE
NCT02809105·Phase 3·INTERVENTIONAL

A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation

Status

Completed

Phase

Phase 3

Enrollment

186

Locations

39

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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

Treatment arms and agents.

DRUG

linaclotide

Oral administration once daily

DRUG

Placebo

Oral administration once daily

Timeline

From registration to results.

  1. First posted

    Jun 22, 2016

  2. Study start

    Jun 24, 2016

  3. Primary completion

    Nov 14, 2016

  4. Study completion

    Nov 10, 2017

  5. Results posted

    Not reported

  6. Registry updated

    Oct 18, 2024

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
20 Years
Maximum age
79 Years
Sex
ALL
Healthy volunteers
No

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

39 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Linaclotide.

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Put the record in context.

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