Chronic ConstipationPhase 2NCT02281630
Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
A Phase 2 study testing KWA-0711 in people with Chronic Constipation, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- KWA-0711
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 1 siteJapan
- Study dates
- 15 Oct 2014to 28 Apr 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment.
- The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation.
Who cannot join
- Patients who have secondary constipation caused by systemic disorder.
- Patients who have organic constipation.
- Patients who received intestinal resection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Randomized, Placebo-controlled, Double-blind, Parallel-group Study of KWA-0711 Administered Orally for 4 Weeks to Evaluate Its Efficacy and Safety, and to Determine Its Optimal Dose in Patients With Chronic Constipation (CC)
The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.
- Conditions
- Chronic Constipation
- Being tested
- KWA-0711, Placebo
- Keywords
- Chronic Constipation, CC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KWA-0711Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KWA-0711 High dose | Experimental | Not described Receives: Drug: KWA-0711 |
| KWA-0711 Low dose | Experimental | Not described Receives: Drug: KWA-0711 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1
Measured: 1 week
Secondary outcomes (12)
Complete SBM (CSBM) frequency and responder rate
Measured: 4 weeks
SBM frequency and responder rate
Measured: 4 weeks
Time to first SBM after the initial dose
Measured: 4 weeks
Stool consistency
Measured: 4 weeks
Degree of straining
Measured: 4 weeks
Abdominal bloating and discomfort
Measured: 4 weeks
Use of rescue medications
Measured: 4 weeks
Global assessment of constipation severity
Measured: 4 weeks
Japanese version of IBS-QOL
Measured: 4 weeks
Global assessment of treatment effectiveness
Measured: 4 weeks
Satisfaction rating for the condition of bowel movements
Measured: 4 weeks
Adverse events, ECGs, vital signs, and clinical labs
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study start15 Oct 2014
- Primary completion28 Apr 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
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatsuro Takei, Study director, Kissei Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281630
- Sponsor's protocol ID
- KWA1204
- Status last verified
- May 2017
- First submitted
- 22 Oct 2014
- Last updated
- 22 May 2017
- Results posted
- No
Publications
Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25.
PubMed 30056028
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Placebo-controlled, Double-blind, Parallel-group Study of KWA-0711 Administered Orally for 4 Weeks to Evaluate Its Efficacy and Safety, and to Determine Its Optimal Dose in Patients With Chronic Constipation (CC)
- ClinicalTrials.gov ID
- NCT02281630
- Acronym / sponsor ID
- KWA1204
- Conditions
- Chronic Constipation
- Keywords
- Chronic Constipation, CC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 28 Apr 2015 (actual)
- First posted
- 3 Nov 2014 (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 purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KWA-0711 High dose | Experimental | Drug: KWA-0711 |
| KWA-0711 Low dose | Experimental | Drug: KWA-0711 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment.
- The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation.
Key exclusion criteria (3 listed)
- Patients who have secondary constipation caused by systemic disorder.
- Patients who have organic constipation.
- Patients who received intestinal resection.
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 |
|---|---|---|
| KWA-0711 | Drug | KWA-0711 High dose, KWA-0711 Low dose |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1
Time frame: 1 week
12 secondary outcomes
Complete SBM (CSBM) frequency and responder rate
Time frame: 4 weeks
SBM frequency and responder rate
Time frame: 4 weeks
Time to first SBM after the initial dose
Time frame: 4 weeks
Stool consistency
Time frame: 4 weeks
Degree of straining
Time frame: 4 weeks
Abdominal bloating and discomfort
Time frame: 4 weeks
Use of rescue medications
Time frame: 4 weeks
Global assessment of constipation severity
Time frame: 4 weeks
Japanese version of IBS-QOL
Time frame: 4 weeks
Global assessment of treatment effectiveness
Time frame: 4 weeks
Satisfaction rating for the condition of bowel movements
Time frame: 4 weeks
Adverse events, ECGs, vital signs, and clinical labs
Time frame: 4 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 22 May 2017.
- Derived from this study: PubMed 30056028Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25.
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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.
Tatsuro Takei study director
Kissei Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KWA-0711 in people with Chronic Constipation, run by Kissei Pharmaceutical Co., Ltd. at 1 site 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 2 inclusion and 3 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 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1 (time frame: 1 week). 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 NCT02281630, 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 22 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.