Chronic ConstipationPhase 4R-LODDNCT05165199
Elobixibat for Chronic Constipation Without Defecation Desire
A Phase 4 study testing Elobixibat 10mg in people with Chronic Constipation, run by Yokohama City University at 1 site in Japan.
Trial summary
Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment… 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?
- Elobixibat 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2022to Mar 2023
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of provisional registration
- Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation
- Age: 20 years or older (at the time of obtaining consent)
- Gender: Any
- outpatients
- Patients for whom written consent can be obtained
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- Patients who can record defecation, etc. in the patient diary
- At the time of registration: Dosing start criteria Patients with the following ・'Loss of defecation desire' in the second week of the observation period (1 week before the start of the treatment period)
- "Loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "4. almost never" or "5. never".
Who cannot join
- At the time of temporary registration Exclude patients with any of the following conditions
- Patients with organ-related constipation or suspected of having organ-related constipation
- Patients with or suspected of having functional ileus
- Patients with or suspected of having inguinal hernia
- Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection)
- Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy
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- Patients with complications of malignancy However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered.
- Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study
- Patients with serious renal, hepatic, or cardiac disease
- Patients with drug allergy to the study drug
- Patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent However, observational studies are excluded.
- Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.
- At the time of registration: Dosing start criteria
- Patients who increased the dose of concomitantly restricted drugs during the observation period
- Patients who used concomitantly prohibited drugs during the observation period
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Yokohama City University
Yokohama, Kanagawa, 236-0004
Takaomi Kessoku, MD., PhD., +81-45-787-2800 ext. 2640, kessoku-tho@umin.ac.jp
About this study
Official title: A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation
Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.
- Conditions
- Chronic Constipation
- Being tested
- Elobixibat 10mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elobixibat 10mgDrug
Patients of chronic constipation with loss of defecation desire are administered Elobixibat 10mg for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Elobixibat | Experimental | 10mg Elobixibat administration for 4 weeks Receives: Drug: Elobixibat 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of change in loss of defecation desire
Percentage of change in loss of defecation desire in the fourth week of the treatment period from the second week of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
Measured: Week 4
Secondary outcomes (13)
Presence of defecation desire
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
Measured: Week 4
Satisfaction with defecation desire
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Measured: Week 4
Satisfaction of straining
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Measured: Week 4
Degree of straining
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Measured: Week 4
Presence of a sense of incomplete evacuation
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Measured: Week 4
Satisfaction with treatment
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Measured: Week 4
Spontaneous bowel movement (SBM) frequency
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Measured: Week 4
Complete Spontaneous Bowel Movement (CSBM) frequency
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Measured: Week 4
Stool hardness based on the Bristol Stool Form Scale
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Measured: Week 4
Constipation severity score
Comparison of the Constipation severity score at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Measured: Week 4
Japanese version of the Patient Assessment of Constipation Quality of Life
Comparison of the Japanese version of the Patient Assessment of Constipation Quality of Life questionrair at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Measured: Week 4
Change of bile acid cocentration
Comparison of the bile acid concentration at Week 4 of the treatment period with Week 2 of the observation period (serum and feces).
Measured: Week 4
Change in defecation time.
Changes in the time from taking elobixibat to defecation each week during the treatment period
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Mar 2022
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yokohama City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takaomi Kessoku, Yokohama City University
- Investigators
- Takaomi Kessoku, M.D., PhD., Principal investigator, Yokohama City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165199
- Sponsor's protocol ID
- 21-008
- Acronym
- R-LODD
- Status last verified
- Mar 2022
- First submitted
- 4 Dec 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohkubo H, Takatsu T, Yoshihara T, Misawa N, Ashikari K, Fuyuki A, Matsuura T, Higurashi T, Yamamoto K, Matsumoto H, Odaka T, Lembo AJ, Nakajima A. Difference in Defecation Desire Between Patients With and Without Chronic Constipation: A Large-Scale Internet Survey. Clin Transl Gastroenterol. 2020 Sep;11(9):e00230. doi: 10.14309/ctg.0000000000000230.
PubMed 32858571Yamamoto A, Kessoku T, Tanaka K, Takahashi K, Kasai Y, Ozaki A, Iwaki M, Kobayashi T, Yoshihara T, Misawa N, Ohkuma K, Fuyuki A, Higurashi T, Hosono K, Yoneda M, Iwasaki T, Kurihashi T, Nakatogawa M, Suzuki A, Taguri M, Oyamada S, Ariyoshi K, Kobayashi N, Ichikawa Y, Nakajima A. Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation. Contemp Clin Trials Commun. 2022 Jun 27;28:100958. doi: 10.1016/j.conctc.2022.100958. eCollection 2022 Aug.
PubMed 35812817
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT05165199
- Acronym / sponsor ID
- R-LODD / 21-008
- Conditions
- Chronic Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yokohama City UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 21 Dec 2021 (actual)
- 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.
Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elobixibat | Experimental | Drug: Elobixibat 10mg10mg Elobixibat administration for 4 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At the time of provisional registration
- Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation
- Age: 20 years or older (at the time of obtaining consent)
- Gender: Any
- outpatients
Key exclusion criteria (15 listed)
- At the time of temporary registration Exclude patients with any of the following conditions
- Patients with organ-related constipation or suspected of having organ-related constipation
- Patients with or suspected of having functional ileus
- Patients with or suspected of having inguinal hernia
- Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis 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 |
|---|---|---|
| Elobixibat 10mgPatients of chronic constipation with loss of defecation desire are administered Elobixibat 10mg for 4 weeks | Drug | Elobixibat |
Primary outcome
Percentage of change in loss of defecation desire
Time frame: Week 4
Percentage of change in loss of defecation desire in the fourth week of the treatment period from the second week of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
13 secondary outcomes
Presence of defecation desire
Time frame: Week 4
Satisfaction with defecation desire
Time frame: Week 4
Satisfaction of straining
Time frame: Week 4
Degree of straining
Time frame: Week 4
Presence of a sense of incomplete evacuation
Time frame: Week 4
Satisfaction with treatment
Time frame: Week 4
Spontaneous bowel movement (SBM) frequency
Time frame: Week 4
Complete Spontaneous Bowel Movement (CSBM) frequency
Time frame: Week 4
Stool hardness based on the Bristol Stool Form Scale
Time frame: Week 4
Constipation severity score
Time frame: Week 4
Japanese version of the Patient Assessment of Constipation Quality of Life
Time frame: Week 4
Change of bile acid cocentration
Time frame: Week 4
Change in defecation time.
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 32858571Ohkubo H, Takatsu T, Yoshihara T, Misawa N, Ashikari K, Fuyuki A, Matsuura T, Higurashi T, Yamamoto K, Matsumoto H, Odaka T, Lembo AJ, Nakajima A. Difference in Defecation Desire Between Patients With and Without Chronic Constipation: A Large-Scale Internet Survey. Clin Transl Gastroenterol. 2020 Sep;11(9):e00230. doi: 10.14309/ctg.0000000000000230.
- Derived from this study: PubMed 35812817Yamamoto A, Kessoku T, Tanaka K, Takahashi K, Kasai Y, Ozaki A, Iwaki M, Kobayashi T, Yoshihara T, Misawa N, Ohkuma K, Fuyuki A, Higurashi T, Hosono K, Yoneda M, Iwasaki T, Kurihashi T, Nakatogawa M, Suzuki A, Taguri M, Oyamada S, Ariyoshi K, Kobayashi N, Ichikawa Y, Nakajima A. Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation. Contemp Clin Trials Commun. 2022 Jun 27;28:100958. doi: 10.1016/j.conctc.2022.100958. eCollection 2022 Aug.
- Individual participant dataSharing planned: No
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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.
Takaomi Kessoku, M.D., PhD. principal investigator
Yokohama City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elobixibat 10mg in people with Chronic Constipation, run by Yokohama City University 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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 23 Mar 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takaomi Kessoku, M.D., PhD. (+81-45-787-2800 ext. 2640, takaomi0027@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of change in loss of defecation desire (time frame: Week 4). 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 NCT05165199, which also lists 2 linked publications.
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 23 Mar 2022.