Chronic ConstipationPhase 3NCT02809105
A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation
A Phase 3 study testing linaclotide in people with Chronic Constipation, run by Astellas Pharma Inc at 39 sites in Japan.
Trial 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. 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?
- linaclotide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 39 sitesJapan
- Study dates
- 24 Jun 2016to 10 Nov 2017
- 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 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:
Show all 14Show fewer
- 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
Who cannot join
- 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
- Improvement with defecation
- Onset associated with a change in frequency of stool
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Japan39 sites
Site JP00029
Aichi
Site JP00030
Aichi
Site JP00021
Chiba
Site JP00022
Chiba
Site JP00023
Chiba
Site JP00024
Chiba
Site JP00040
Fukuoka
Site JP00001
Hokkaido
Site JP00002
Hokkaido
Site JP00037
Hyōgo
Site JP00038
Hyōgo
Site JP00039
Hyōgo
Site JP00017
Kanagawa
Site JP00018
Kanagawa
Site JP00019
Kanagawa
Site JP00020
Kanagawa
Site JP00031
Osaka
Site JP00032
Osaka
Site JP00033
Osaka
Site JP00034
Osaka
Site JP00035
Osaka
Site JP00036
Osaka
Site JP00025
Saitama
Site JP00026
Saitama
Site JP00027
Saitama
Site JP00028
Saitama
Site JP00003
Tokyo
Site JP00004
Tokyo
Site JP00005
Tokyo
Site JP00006
Tokyo
Site JP00007
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
About this study
Official title: Phase 3 Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and an Open-label, Uncontrolled, Long-term Dosing Study in Patients With Chronic Constipation (Not Including Constipation Due to Organic Diseases) -
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.
Read the 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.
- Conditions
- Chronic Constipation
- Being tested
- linaclotide, Placebo
- Keywords
- Chronic constipation, Linaclotide, ASP0456
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 group | Role | What they receive |
|---|---|---|
| Part I ASP0456 | Experimental | ASP0456 will be administered orally for 4 weeks. Receives: Drug: linaclotide |
| Part I Placebo | Placebo comparator | Placebo will be administered orally for 4 weeks. Receives: Drug: Placebo |
| Part II ASP0456 | Experimental | ASP0456 will be administered orally. Receives: Drug: linaclotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weekly mean SBM frequency during one week of administration (Part I)
SBM: Spontaneous bowel movement
Measured: Baseline and Week 1
Secondary outcomes (19)
Change from baseline in weekly mean SBM frequency
Measured: Baseline and up to Week 56
Weekly responder rate of 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: Baseline and up to Week 56
Percentage of subjects with SBM within 24 hours after the start of the initial administration
Measured: Up to 24h
Time to first SBM
Measured: Up to Week 4
Change from baseline in weekly mean CSBM frequency
CSBM: SBM without a sensation of incomplete evacuation
Measured: Baseline and up to Week 56
Weekly responder rate of 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: Baseline and up to Week 56
Percentage of subjects with CSBM within 24 hours after the start of the initial administration
Measured: Up to 24h
Change from baseline in weekly mean stool form score
Stool form will be measured using seven-point Bristol Stool Form Scale.
Measured: Baseline and up to Week 56
Change from baseline in weekly mean abdominal bloating severity score
Abdominal bloating severity will be measured using a five-point ordinal score.
Measured: Baseline and up to Week 56
Change from baseline in weekly mean abdominal pain/discomfort severity score
Abdominal pain/discomfort severity will be measured using a five-point ordinal score.
Measured: Baseline and up to Week 56
Change from baseline in weekly mean straining severity score
Straining severity will be measured using a five-point ordinal score.
Measured: Baseline and up to Week 56
Weekly responder rate of global assessment of relief of CC symptoms
CC: 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 Week 56
Weekly responder rate of abnormal bowel habits improvement in CC
Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2.
Measured: Up to Week 56
Weekly responder rate of abdominal symptoms relief of CC
Score of abdominal symptom improvement effect (7 scores: 1-7) is 1 or 2.
Measured: Up to Week 56
Change from baseline in IBS-QOL-J score
IBS-QOL-J: Japanese version of Irritable Bowel Syndrome Quality of Life
Measured: Baseline and up to Week 56
Safety assessed by incidence of adverse events
Measured: Up to Week 56
Number of participants with abnormal Vital signs and/or adverse events during treatment period
Measured: Up to Week 56
Number of participants with abnormal Laboratory values and/or adverse events during treatment period
Measured: Up to Week 56
Safety assessed by body weight
Measured: Up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start24 Jun 2016
- Primary completion14 Nov 2016
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 186 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
- NCT02809105
- Sponsor's protocol ID
- 0456-CL-1031
- Status last verified
- Oct 2024
- First submitted
- 20 Jun 2016
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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/.
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 3 Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and an Open-label, Uncontrolled, Long-term Dosing Study in Patients With Chronic Constipation (Not Including Constipation Due to Organic Diseases) -
- ClinicalTrials.gov ID
- NCT02809105
- Acronym / sponsor ID
- 0456-CL-1031
- Conditions
- Chronic Constipation
- Keywords
- Chronic constipation, Linaclotide, ASP0456
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2016 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 22 Jun 2016 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I ASP0456 | Experimental | Drug: linaclotideASP0456 will be administered orally for 4 weeks. |
| Part I Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered orally for 4 weeks. |
| Part II ASP0456 | Experimental | Drug: linaclotideASP0456 will be administered orally. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (18 listed)
- 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
- 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
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 administration once daily | Drug | Part I ASP0456, Part II ASP0456 |
| PlaceboOral administration once daily | Drug | Part I Placebo |
Primary outcome
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
19 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
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
Weekly responder rate of CSBM
Time frame: Baseline and up to Week 56
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
Change from baseline in weekly mean abdominal bloating severity score
Time frame: Baseline and up to Week 56
Change from baseline in weekly mean abdominal pain/discomfort severity score
Time frame: Baseline and up to Week 56
Change from baseline in weekly mean straining severity score
Time frame: Baseline and up to Week 56
Weekly responder rate of global assessment of relief of CC symptoms
Time frame: Up to Week 56
Weekly responder rate of abnormal bowel habits improvement in CC
Time frame: Up to Week 56
Weekly responder rate of abdominal symptoms relief of CC
Time frame: Up to Week 56
Change from baseline in IBS-QOL-J score
Time frame: Baseline and up to Week 56
Safety assessed by incidence of adverse events
Time frame: Up to Week 56
Number of participants with abnormal Vital signs and/or adverse events during treatment period
Time frame: Up to Week 56
Number of participants with abnormal Laboratory values and/or adverse events during treatment period
Time frame: Up to Week 56
Safety assessed by body weight
Time frame: Up to Week 56
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: 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
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing linaclotide in people with Chronic Constipation, run by Astellas Pharma Inc at 39 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 14 inclusion and 18 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 39 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?
Change from baseline in weekly mean SBM frequency during one week of administration (Part I) (time frame: Baseline and Week 1). 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.