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Irritable Bowel Syndrome With Constipation (IBS-C)Phase 3NCT02316899

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

A Phase 3 study testing linaclotide in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Astellas Pharma Inc at 61 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 20 to 79 years
What is being tested?
linaclotide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
61 sitesJapan
Study dates
21 Oct 2014to 29 Mar 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

Japan61 sites

  • Site JP00004

    Aichi

  • Site JP00048

    Aichi

  • Site JP00049

    Aichi

  • Site JP00038

    Chiba

  • Site JP00039

    Chiba

  • Site JP00040

    Chiba

  • Site JP00041

    Chiba

  • Site JP00042

    Chiba

  • Site JP00002

    Fukuoka

  • Site JP00060

    Fukuoka

  • Site JP00061

    Fukuoka

  • Site JP00001

    Hokkaido

  • Site JP00006

    Hokkaido

  • Site JP00007

    Hokkaido

  • Site JP00057

    Hyōgo

  • Site JP00058

    Hyōgo

  • Site JP00059

    Hyōgo

  • Site JP00030

    Kanagawa

  • Site JP00031

    Kanagawa

  • Site JP00032

    Kanagawa

  • Site JP00033

    Kanagawa

  • Site JP00034

    Kanagawa

  • Site JP00035

    Kanagawa

  • Site JP00036

    Kanagawa

  • Site JP00037

    Kanagawa

  • Site JP00056

    Kyoto

  • Site JP00003

    Osaka

  • Site JP00050

    Osaka

  • Site JP00051

    Osaka

  • Site JP00052

    Osaka

  • Site JP00053

    Osaka

  • Site JP00054

    Osaka

  • Site JP00055

    Osaka

  • Site JP00043

    Saitama

  • Site JP00044

    Saitama

  • Site JP00045

    Saitama

  • Site JP00046

    Saitama

  • Site JP00047

    Saitama

  • Site JP00005

    Tokyo

  • Site JP00008

    Tokyo

  • Site JP00009

    Tokyo

  • Site JP00010

    Tokyo

  • Site JP00011

    Tokyo

  • Site JP00012

    Tokyo

  • Site JP00013

    Tokyo

  • Site JP00014

    Tokyo

  • Site JP00015

    Tokyo

  • Site JP00016

    Tokyo

  • Site JP00017

    Tokyo

  • Site JP00018

    Tokyo

  • Site JP00019

    Tokyo

  • Site JP00020

    Tokyo

  • Site JP00021

    Tokyo

  • Site JP00022

    Tokyo

  • Site JP00023

    Tokyo

  • Site JP00024

    Tokyo

  • Site JP00025

    Tokyo

  • Site JP00026

    Tokyo

  • Site JP00027

    Tokyo

  • Site JP00028

    Tokyo

  • Site JP00029

    Tokyo

Other trials in Japan

About this study

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)

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

Read the detailed description

<Period I (double-blind period)> 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.

<Period II (non-blind period)> 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.

Being tested
linaclotide, Placebo
Keywords
ASP0456, constipation, linaclotide, irritable bowel syndrome (IBS)
Medical subject headings
Constipation, Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • linaclotideDrug

    Also called ASP0456

    Oral administration once daily

  • PlaceboDrug

    Oral administration once daily

Study groups in NCT02316899
Study groupRoleWhat they receive
ASP0456 (Period I)ExperimentalUp to 12 weeks
Receives: Drug: linaclotide
Placebo (Period I)Placebo comparatorUp to 12 weeks
Receives: Drug: Placebo
ASP0456 (Period II)ExperimentalFrom 12 weeks to 52 weeks
Receives: Drug: linaclotide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During 12 weeks

  2. 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.

    Measured: During 12 weeks

Secondary outcomes (13)

  1. Responder rate of SBM during 12 weeks

    SBM: Spontaneous Bowel Movement

    Measured: During 12 weeks

  2. Responder rate of Abnormal bowel habits improvement during 12 weeks

    Measured: During 12 weeks

  3. Responder rate of Abdominal pain/discomfort relief during 12 weeks

    Measured: During 12 weeks

  4. 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

    Measured: Up to 52 weeks

  5. 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

    Measured: Up to 52 weeks

  6. 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

    Measured: Up to 52 weeks

  7. Weekly responder rate of Abnormal bowel habits improvement

    Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2

    Measured: Up to 52 weeks

  8. Weekly responder rate of Abdominal pain/discomfort relief

    Score of abdominal pain/discomfort improvement effect (7 scores: 1-7) is 1 or 2.

    Measured: Up to 52 weeks

  9. Changes in weekly average of SBM frequency, CSBM frequency, stool form scores, abdominal pain/discomfort severity, abdominal bloating severity, and straining severity.

    Measured: From baseline to every week until 52 weeks

  10. 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

    Measured: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 40, 52

  11. Percentage of subjects with SBM within 24 hours after start of the initial administration

    Measured: Up to 24 hours

  12. Percentage of subjects with CSBM within 24 hours after start of the initial administration

    Measured: Up to 24 hours

  13. Safety assessed by development of incidence of adverse events, vital signs, and clinical laboratory tests

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2014 (estimated)
  2. Study start21 Oct 2014
  3. Primary completion19 Sep 2015
  4. Study completion29 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02316899
Sponsor's protocol ID
0456-CL-0031
Status last verified
Oct 2024
First submitted
4 Dec 2014
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: 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/.

Publications

  • 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.

    PubMed 30136447

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing linaclotide in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Astellas Pharma Inc at 61 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rate of Global assessment of relief of IBS symptoms during 12 weeks. (time frame: During 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02316899, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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