Chronic ConstipationPhase 2NCT02425722

A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation

A Phase 2 study testing ASP0456 in people with Chronic Constipation, run by Astellas Pharma Inc at 50 sites in Japan.

Completed

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

Trial summary

The objective of this study is to investigate dose-responses of efficacy and safety of ASP0456 in patients with chronic constipation (diagnosed by Rome III criteria of functional constipation (FC), not including constipation due to organic diseases) compared to placebo and to find the appropriate dose for P3 study. Read more about this study

Who is it for?: Ages 20 to 79 years
Conditions the study is for: Chronic Constipation
What is being tested?: ASP0456
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 383 participants
Where: 50 sitesJapan
Study dates: 13 Apr 2015to 31 Oct 2015
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 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient who had SBM* (Spontaneous bowel movement) less than 3 times per week, more than six months prior to the provisional registration
*Defecation without procedure of laxative, suppository, enema, or stool extraction on the day or preceding day of the defecation
Patient who was affected with one or more following symptoms before more than six months of provisional registration:
Straining during at least 25% of defecations
Lumpy or hard stools in at least 25% of defecations
Sensation of incomplete evacuation for at least 25% of defecations
Loose stools are rarely present without the use of laxatives more than six months prior to the provisional registration.
Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of chronic constipation symptom and had no organic changes

Who cannot join

Patient who has met IBS-C diagnostic criteria from Rome III more than six months prior to provisional registration. Meaning that patient who had recurrent abdominal pain or discomfort at least 3 days/month in last 3 months associated with two or more of the following, and patient who was affected with following IBS symptoms more than six months prior to the provisional registration:
Improvement with defecation
Onset associated with a change in frequency of stool
Onset associated with a change in form (appearance) of stool
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 evidence of inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Show all 22Show fewer

Patient with history or current evidence of ischemic colitis
Patient currently affected by infectious enteritis
Patient currently affected by hyperthyroidism or hypothyroidism
Patient with apparent mechanical obstruction (i.e. patient with ileus caused by hernia)
Patient with mega colon or mega rectum
Patient currently affected by constipation due to anorectal dysfunction
Patient currently affected by drug induced constipation.
Patient with constipation due to other organic disease
Patient currently affected by active peptic ulcer
In the case of a female, 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 (however, patient who used or underwent restricted drug/therapy according to Protocol may be enrolled provisionally)
Patient with history or current evidence of malignant tumor
Patient currently affected by serious cardiovascular disease, respiratory disease, kidney disease, hepatic disease, gastrointestinal disease (excluding CC), hemorrhagic disease, or neural/mental disease
Patient with history of drug allergy

Trial locations and contacts

50 sites in 1 country.

City, postcode or hospital

50 sites in 1 country

Japan50 sites

Site: 35
Aichi
Site: 36
Aichi
Site: 27
Chiba
Site: 28
Chiba
Site: 29
Chiba
Site: 30
Chiba
Site: 48
Fukuoka
Site: 49
Fukuoka
Site: 50
Fukuoka
Site: 1
Hokkaido
Site: 2
Hokkaido
Site: 45
Hyōgo
Site: 46
Hyōgo
Site: 47
Hyōgo
Site: 22
Kanagawa
Site: 23
Kanagawa
Site: 24
Kanagawa
Site: 25
Kanagawa
Site: 26
Kanagawa
Site: 44
Kyoto
Site: 37
Osaka
Site: 38
Osaka
Site: 39
Osaka
Site: 40
Osaka
Site: 41
Osaka
Site: 42
Osaka
Site: 43
Osaka
Site: 31
Saitama
Site: 32
Saitama
Site: 33
Saitama
Site: 34
Saitama
Site: 10
Tokyo
Site: 11
Tokyo
Site: 12
Tokyo
Site: 13
Tokyo
Site: 14
Tokyo
Site: 15
Tokyo
Site: 16
Tokyo
Site: 17
Tokyo
Site: 18
Tokyo
Site: 19
Tokyo
Site: 20
Tokyo
Site: 21
Tokyo
Site: 3
Tokyo
Site: 4
Tokyo
Site: 5
Tokyo
Site: 6
Tokyo
Site: 7
Tokyo
Site: 8
Tokyo
Site: 9
Tokyo

Other trials in Japan

About this study

Official title: Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Chronic Constipation (Not Including Constipation Due to Organic Diseases)

Read the detailed description

To determine optimum dose of ASP0456 for the patients with chronic constipation (not including constipation due to organic diseases) in Japan based on its efficacy and safety, multicentered, placebo-controlled, double-blind, parallel group comparative study will be conducted.

After two-week observation period, the patient who meets the primary registration criteria will be randomized to the one from five groups and will start treatment period. The patients will take once daily orally before the breakfast for two weeks.

Conditions: Chronic Constipation
Being tested: ASP0456, Placebo
Keywords: linaclotide, ASP0456, chronic constipation

What participants receive

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

ASP0456Drug
Also called Linaclotide
oral
PlaceboDrug
oral

Study groups in NCT02425722
Study group	Role	What they receive
ASP0456 0.0625mg	Experimental	oral Receives: Drug: ASP0456
ASP0456 0.125mg	Experimental	oral Receives: Drug: ASP0456
ASP0456 0.25mg	Experimental	oral Receives: Drug: ASP0456
ASP0456 0.5mg	Experimental	oral Receives: Drug: ASP0456
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.

Change in weekly average of SBM frequency
SBM: Spontaneous Bowel Movement. SBM means the defecation without procedure of laxative, suppository, enema, or stool extraction on the day or preceding day of the defecation. SBM frequency is calculated as follows: (the week total number of SBM )/ (the total number of days on which the frequency of SBM is evaluable) x7
Measured: From baseline to week 1

Secondary outcomes (19)

Weekly responder rate for SBM
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
Measured: up to 2 weeks
Weekly responder rate for CSBM
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
Measured: up to 2 weeks
Percentage of subjects with SBM within 24 hours after the start of initial treatment
Measured: up to 24 hours
Change in weekly average of CSBM frequency
Measured: From baseline to week 1
Proportion of subjects with CSBM within 24 hours after the start of initial treatment
Measured: up to 24 hours
Weekly responder rate of the global assessment of relief of chronic constipation.
The weekly responder of the evaluation items shall be the subject satisfying the following at the time of evaluation in each week: Score of Global assessment of relief of chronic constipation symptoms (7 scores: 1-7) is 1 or 2
Measured: up to 2 weeks
Weekly responder rate of the abdominal bowel habits improvement in chronic constipation.
Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2
Measured: up to 2 weeks
Weekly responder rate of abdominal symptom relief of chronic constipation.
Score of abdominal symptom improvement effect (7 scores: 1-7) is 1 or 2
Measured: up to 2 weeks
Score of the global assessment of relief of chronic constipation
Scores will be measured using a seven-point ordinal score
Measured: up to 2 weeks
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: Week 0, and 2
Changes in weekly average of SBM frequency
SBM: Spontaneous Bowel Movement
Measured: From baseline to every week until 2 weeks
Changes in weekly average of CSBM frequency
CSBM: Complete Spontaneous Bowel Movement
Measured: From baseline to every week until 2 weeks
Changes in weekly average of stool form
Stool form will be measured using seven-point Bristol Stool Form Scale
Measured: From baseline to every week until 2 weeks
Changes in weekly average of abdominal bloating severity scores
Abdominal bloating severity will be measured using a five-point ordinal score
Measured: From baseline to every week until 2 weeks
Changes in weekly average of abdominal pain/discomfort severity scores
Abdominal pain/discomfort severity will be measured using a five-point ordinal score
Measured: From baseline to every week until 2 weeks
Changes in weekly average of straining severity scores
Straining severity will be measured using a five-point ordinal score
Measured: From baseline to every week until 2 weeks
Score of the abdominal bowel habits improvement in chronic constipation
Scores will be measured using a seven-point ordinal score
Measured: up to 2 weeks
Score of the abdominal symptom relief of chronic constipation
Scores will be measured using a seven-point ordinal score
Measured: up to 2 weeks
Safety assessed by development of incidence of adverse events, vital signs, clinical laboratory tests and body weight
Measured: up to 2 weeks

Timeline

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

13 Apr 201531 Oct 2015

First posted24 Apr 2015 (estimated)
Study start13 Apr 2015
Primary completion31 Oct 2015
Study completion31 Oct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic ConstipationStudies 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: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02425722
Sponsor's protocol ID: 0456-CL-1021
Status last verified: Oct 2024
First submitted: 7 Apr 2015
Last updated: 18 Oct 2024
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

Fukudo S, Miwa H, Nakajima A, Kinoshita Y, Kosako M, Nakagawa A, Akiho H, Kuroishi K, Johnston JM, Currie M, Ohkusa T. Dose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study. Neurogastroenterol Motil. 2018 Dec;30(12):e13442. doi: 10.1111/nmo.13442. Epub 2018 Aug 7.
PubMed 30084233

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Constipation

All Chronic Constipation trials

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 Chronic Constipation (Not Including Constipation Due to Organic Diseases)
ClinicalTrials.gov ID: NCT02425722
Acronym / sponsor ID: 0456-CL-1021
Conditions: Chronic Constipation
Keywords: linaclotide, ASP0456, chronic constipation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Study start: 13 Apr 2015 (actual)
Primary completion: 31 Oct 2015 (actual)
Study completion: 31 Oct 2015 (actual)
First posted: 24 Apr 2015 (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.

Detailed description

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 0.0625mg	Experimental	Drug: ASP0456oral
ASP0456 0.125mg	Experimental	Drug: ASP0456oral
ASP0456 0.25mg	Experimental	Drug: ASP0456oral
ASP0456 0.5mg	Experimental	Drug: ASP0456oral
Placebo group	Placebo comparator	Drug: Placebooral

Who may qualify

Ages: 20 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient who had SBM* (Spontaneous bowel movement) less than 3 times per week, more than six months prior to the provisional registration
Patient who was affected with one or more following symptoms before more than six months of provisional registration:
Loose stools are rarely present without the use of laxatives more than six months prior to the provisional registration.
Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of chronic constipation symptom and had no organic changes

Key exclusion criteria (22 listed)

Patient who has met IBS-C diagnostic criteria from Rome III more than six months prior to provisional registration. Meaning that patient who had recurrent abdominal pain or discomfort at least 3 days/month in last 3 months associated with two or more of the following, and patient who was affected with following IBS symptoms more than six months prior to the provisional registration:
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 evidence of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Patient with history or current evidence of ischemic colitis
Patient currently affected by infectious enteritis

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
ASP0456Also: Linaclotideoral	Drug	ASP0456 0.0625mg, ASP0456 0.125mg, ASP0456 0.25mg, ASP0456 0.5mg
Placebooral	Drug	Placebo group

Primary outcome

Change in weekly average of SBM frequency
Time frame: From baseline to week 1
SBM: Spontaneous Bowel Movement. SBM means the defecation without procedure of laxative, suppository, enema, or stool extraction on the day or preceding day of the defecation. SBM frequency is calculated as follows: (the week total number of SBM )/ (the total number of days on which the frequency of SBM is evaluable) x7

19 secondary outcomes

Weekly responder rate for SBM
Time frame: up to 2 weeks
Weekly responder rate for CSBM
Time frame: up to 2 weeks
Percentage of subjects with SBM within 24 hours after the start of initial treatment
Time frame: up to 24 hours
Change in weekly average of CSBM frequency
Time frame: From baseline to week 1
Proportion of subjects with CSBM within 24 hours after the start of initial treatment
Time frame: up to 24 hours
Weekly responder rate of the global assessment of relief of chronic constipation.
Time frame: up to 2 weeks
Weekly responder rate of the abdominal bowel habits improvement in chronic constipation.
Time frame: up to 2 weeks
Weekly responder rate of abdominal symptom relief of chronic constipation.
Time frame: up to 2 weeks
Score of the global assessment of relief of chronic constipation
Time frame: up to 2 weeks
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
Time frame: Week 0, and 2
Changes in weekly average of SBM frequency
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of CSBM frequency
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of stool form
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of abdominal bloating severity scores
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of abdominal pain/discomfort severity scores
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of straining severity scores
Time frame: From baseline to every week until 2 weeks
Score of the abdominal bowel habits improvement in chronic constipation
Time frame: up to 2 weeks
Score of the abdominal symptom relief of chronic constipation
Time frame: up to 2 weeks
Safety assessed by development of incidence of adverse events, vital signs, clinical laboratory tests and body weight
Time frame: up to 2 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.
Derived from this study: PubMed 30084233Fukudo S, Miwa H, Nakajima A, Kinoshita Y, Kosako M, Nakagawa A, Akiho H, Kuroishi K, Johnston JM, Currie M, Ohkusa T. Dose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study. Neurogastroenterol Motil. 2018 Dec;30(12):e13442. doi: 10.1111/nmo.13442. Epub 2018 Aug 7.
Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Related trials for Chronic Constipation

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Constipation

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

50 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 ASP0456 in people with Chronic Constipation, run by Astellas Pharma Inc at 50 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 8 inclusion and 22 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 50 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?

Change in weekly average of SBM frequency (time frame: From baseline to week 1). 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 NCT02425722, 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.