Constipation-predominant Irritable Bowel Syndrome (IBS-C)Phase 2NCT01714843
A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
A Phase 2 study testing linaclotide in people with Constipation-predominant Irritable Bowel Syndrome (IBS-C), run by Astellas Pharma Inc at 4 sites in Japan.
Trial summary
This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Constipation-predominant Irritable Bowel Syndrome (IBS-C)
- 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
- 559 participants
- Where
- 4 sitesJapan
- Study dates
- 10 Aug 2012to 7 Dec 2013
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- 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
- Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
- Patients with other concurrent diseases that may affect the digestive tract passage or large intestinal function
- Patients with other concurrent diseases that may affect the assessment of abdominal pain/discomfort
- Patients with blood pressure, pulse rate, clinical laboratory test, or 12-lead ECG at the time of screening examination that was rated as Grade 2 or greater on the "Severity Criteria for Drug Adverse Reaction" and judged to be clinically significant
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyusyu
About this study
Official title: Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Constipation-predominant Irritable Bowel Syndrome
This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.
Read the detailed description
This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after oral administration of ASP0456.
- Being tested
- linaclotide, placebo
- Keywords
- irritable bowel syndrome (IBS), linaclotide, constipation, ASP0456
- Medical subject headings
- Irritable Bowel Syndrome, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linaclotideDrug
Also called ASP0456
oral
placeboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP0456 lowest dose group | Experimental | oral Receives: Drug: linaclotide |
| ASP0456 low dose group | Experimental | oral Receives: Drug: linaclotide |
| ASP0456 middle dose group | Experimental | oral Receives: Drug: linaclotide |
| ASP0456 high dose group | Experimental | oral Receives: Drug: linaclotide |
| placebo group | Placebo comparator | oral Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global assessment of relief of IBS symptoms Responder
Measured: Weekly for 12 weeks
Secondary outcomes (11)
SBM (Spontaneous Bowel Movement) Responder
Measured: Weekly for 12 weeks
CSBM (Complete SBM) Responder
Measured: Weekly for 12 weeks
Abnormal bowel habits improvement Responder
Measured: Weekly for 12 weeks
Abdominal pain/discomfort relief Responder
Measured: Weekly for 12 weeks
Changes in weekly average of SBM frequency
Measured: Weekly for 12 weeks
Changes in weekly average of CSBM frequency
Measured: Weekly for 12 weeks
Changes in weekly average of stool form scores
Measured: Weekly for 12 weeks
Changes in weekly average of abdominal pain/discomfort severity
Measured: Weekly for 12 weeks
Changes in weekly average of straining severity
Measured: Weekly for 12 weeks
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
Measured: Weekly for 12 weeks
Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs
Measured: for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study start10 Aug 2012
- Primary completion7 Dec 2013
- Study completion7 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation-predominant Irritable Bowel Syndrome (IBS-C)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714843
- Sponsor's protocol ID
- 0456-CL-0021
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2012
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Constipation-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01714843
- Acronym / sponsor ID
- 0456-CL-0021
- Keywords
- irritable bowel syndrome (IBS), linaclotide, constipation, ASP0456
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2012 (actual)
- Primary completion
- 7 Dec 2013 (actual)
- Study completion
- 7 Dec 2013 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.
Detailed description
This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after oral administration of ASP0456.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ASP0456 lowest dose group | Experimental | Drug: linaclotideoral |
| ASP0456 low dose group | Experimental | Drug: linaclotideoral |
| ASP0456 middle dose group | Experimental | Drug: linaclotideoral |
| ASP0456 high dose group | Experimental | Drug: linaclotideoral |
| placebo group | Placebo comparator | Drug: placebooral |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
- Patients with other concurrent diseases that may affect the digestive tract passage or large intestinal function
- Patients with other concurrent diseases that may affect the assessment of abdominal pain/discomfort
- Patients with blood pressure, pulse rate, clinical laboratory test, or 12-lead ECG at the time of screening examination that was rated as Grade 2 or greater on the "Severity Criteria for Drug Adverse Reaction" and judged to be clinically significant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| linaclotideAlso: ASP0456oral | Drug | ASP0456 high dose group, ASP0456 low dose group, ASP0456 lowest dose group, ASP0456 middle dose group |
| placebooral | Drug | placebo group |
Primary outcome
Global assessment of relief of IBS symptoms Responder
Time frame: Weekly for 12 weeks
11 secondary outcomes
SBM (Spontaneous Bowel Movement) Responder
Time frame: Weekly for 12 weeks
CSBM (Complete SBM) Responder
Time frame: Weekly for 12 weeks
Abnormal bowel habits improvement Responder
Time frame: Weekly for 12 weeks
Abdominal pain/discomfort relief Responder
Time frame: Weekly for 12 weeks
Changes in weekly average of SBM frequency
Time frame: Weekly for 12 weeks
Changes in weekly average of CSBM frequency
Time frame: Weekly for 12 weeks
Changes in weekly average of stool form scores
Time frame: Weekly for 12 weeks
Changes in weekly average of abdominal pain/discomfort severity
Time frame: Weekly for 12 weeks
Changes in weekly average of straining severity
Time frame: Weekly for 12 weeks
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
Time frame: Weekly for 12 weeks
Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs
Time frame: for 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: 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/.
Related trials for Constipation-predominant Irritable Bowel Syndrome (IBS-C)
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"Efficacy and Safety of Linaclotide in Chronic Constipation"
Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C)
Not yet recruitingObservational study
Soluble and Osmotic Fibre (SOLOS) Diet for Constipation
Constipation, Constipation - Functional
Not yet recruiting
Effect of Functional Magnetic Therapy on Constipation Predominant- Irritable Bowel Syndrome (IBS-C)
Irritable Bowel Syndrome
Recruiting
The Beneficial Effects on the Intestinal Function of a Food Supplement Based on an Extract of Green Tea and a Pool of Probiotics in Subjects With Irritable Bowel Syndrome With Predominance of Constipation
IBS, Constipation Predominant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing linaclotide in people with Constipation-predominant Irritable Bowel Syndrome (IBS-C), run by Astellas Pharma Inc at 4 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 4 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 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Global assessment of relief of IBS symptoms Responder (time frame: Weekly for 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.