Chronic ConstipationPhase 2NCT01937663
A Single-blind, Dose-tapering Study of KWA-0711 in Patients With Chronic Constipation
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 tapered KWA-0711 dose in chronic constipation 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?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Start not givento Jan 2014
- 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 spontaneous bowel movements 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
The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in chronic constipation patients.
- Conditions
- Chronic Constipation
- Being tested
- KWA-0711
- Keywords
- Chronic Constipation, Constipation, Functional gastrointestinal disorders
- Medical subject headings
- Constipation, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KWA-0711Drug
| Study group | Role | What they receive |
|---|---|---|
| KWA-0711 Dose1 | Experimental | Not described Receives: Drug: KWA-0711 |
| KWA-0711 Dose2 | Experimental | Not described Receives: Drug: KWA-0711 |
| KWA-0711 Dose3 | Experimental | Not described Receives: Drug: KWA-0711 |
| KWA-0711 Dose4 | Experimental | Not described Receives: Drug: KWA-0711 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of signs and symptoms associated with constipation
- Frequency of Spontaneous Bowel Movements
- Bowel Movement Timing
- Stool Consistency
- Abdominal Assessment
- QOL Assessment
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 posted9 Sep 2013 (estimated)
- Primary completionJan 2014
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 2
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937663
- Sponsor's protocol ID
- KWA1203
- Status last verified
- Nov 2014
- First submitted
- 27 Aug 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Dose-tapering Study of KWA-0711 in Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT01937663
- Acronym / sponsor ID
- KWA1203
- Conditions
- Chronic Constipation
- Keywords
- Chronic Constipation, Constipation, Functional gastrointestinal disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- Jan 2014 (actual)
- First posted
- 9 Sep 2013 (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 tapered KWA-0711 dose in chronic constipation patients.
Study design
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KWA-0711 Dose1 | Experimental | Drug: KWA-0711 |
| KWA-0711 Dose2 | Experimental | Drug: KWA-0711 |
| KWA-0711 Dose3 | Experimental | Drug: KWA-0711 |
| KWA-0711 Dose4 | Experimental | Drug: KWA-0711 |
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 spontaneous bowel movements 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 Dose1, KWA-0711 Dose2, KWA-0711 Dose3, KWA-0711 Dose4 |
Primary outcome
Improvement of signs and symptoms associated with constipation
Time frame: 4 weeks
* Frequency of Spontaneous Bowel Movements * Bowel Movement Timing * Stool Consistency * Abdominal Assessment * QOL Assessment
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 13 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 13 Nov 2014. 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. 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?
Improvement of signs and symptoms associated with constipation (time frame: 4 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 13 Nov 2014.