Effects of Elobixibat on rectal visceral perception in constipated patients over 60 years of age

JRCT ID: jRCTs061200030

Registered date:01/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: chronic constipation
• Date of first enrollment: 18/02/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Randomized administration of Elobixibat or placebo as study drug

Outcome(s)

• Primary Outcome: Change in rectal defecatory urge sensory threshold (at 1-week: ml) from before administration

Secondary Outcome

- Change in rectal sensory threshold, Minimum, and Maximum tolerated threshold (at 1-week: ml) from before administration
-Change in rectal sensory threshold, Minimum, Defecatory urge and Maximum tolerated threshold (at 1-week: mmHg) from before administration
-Change in percentage of rectal Minimum, Defecatory urge and Maximum tolerated threshold to rectal capacity (1 week:%) from before administration
-Change in Rectal Compliance (mL / mmHg) from before administration
-Comparison of Rectal Compliance (mL / mmHg) between healthy adults and chronic constipation patients
-Change in frequency of Spontaneous Bowel Movement (1 week: times / week) from observation period
- Change in frequency of complete Spontaneous Bowel Movement (1 week: times / week) from observation period
- Bristol Stool Form Scale
- Comparison of Rectal Sensory Threshold Test Values between Healthy Adults and Chronic Constipation Patients
- Use of rescue medication
-Changes in distribution of stool and gas by abdominal ultrasonography
- Fecal bile acid
- Subpopulation analysis by background factors
- Pattern of dosage increase or decrease
- Defecation desire due to subjective symptoms

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Subjects who meet every those following criteria.

Patients with chronic constipation:
<At the time of temporary registration>
1)Patients who meet every those following criteria
Subjects who have had subjective symptoms of chronic constipation for more than 6 months and have met the following criteria for the last 3 months.
1. There are two or more of the following symptoms.
-Straining among more than 25% of defecations.
-Feeling of obstruction or a feeling of fullness of the rectal anus more than 25% of defecations.
-Scybalum or hard stool among more than 25% of defecations.
-Manual maneuvers to facilitate more than 25% of defecations (stool extraction, Oppression the pelvic floor, etc.).
-Feeling of unsatisfied defecation among more than 25% of defecations.
-Defecation less than three times a week.
2. Soft stool rarely occurs when laxatives are not used.
3. Does not meet the criteria for irritable bowel syndrome (IBS).
2) Age : Over 60 years at the time of informed consent.
3) Ability to provide written informed consent.

Healthy adult subjects :
<At the time of temporary registration>
1) Subjects who have bowel movements almost every day from more than 6 months prior to informed consent.
2) Age : Over 60 years at the time of informed consent
3) Ability to provide written informed consent
4) No comorbidities

Exclude criteria

Subjects who meet any of the following criteria are not included.

Patients with chronic constipation:
<At the time of temporary registration>
1) Patients with or suspected organic constipation, outlet obstruction type constipation
2) Patients with suspected biliary obstruction or decreased bile secretion
3) Patients who not able to use rescue medication (Bisacodyl suppositories 10 mg)
4) Patients with malignant tumor
5) Patients with a medical history of hypersensitivity to Elobixibat.
6) Patients who are taking bile acid preparations (ursodeoxycholic acid, chenodeoxycholic acid), aluminum-containing preparations (sucralfate hydrate, aldioxa, etc.), cholestyramine, colestimide, digoxin, Dabigatran etexilate methanesulfonate, or midazolam
7) Patients who were considered as ineligible by the investigator/sub-investigator for any other reasons
8) Patients who have serious disease related to the kidney (creatinine>=2.00 mg/dL)or the liver (total bilirubin >=3.0 mg/dL or AST or ALT >=100 U/L) or the heart at the time of Visit-1

<At the time of registration>
9) Patients who used the rescue medication(Bisacodyl suppositories 10 mg) over three times during the 1-week observation period
10) Patients who used the rescue medication less than 72 hours after bowel movement during the 1-week observation period
11) Patients with soft stool or watery stool (Bristol Stool Form Scale type 6 or 7) due to spontaneous evacuation of stool, during the 1-week observation period
12)Patients who used prohibited medications and prohibited therapies during the 1-week observation period

Healthy adult subjects :
<At the time of temporary registration/registration>
1) Subjects who have serious disease related to the kidney (creatinine>=2.00 mg/dL)or the liver (total bilirubin >=3.0 mg/dL or AST or ALT >=100 U/L) or the heart at inspection within the past 1 year
2) Subjects who were considered as ineligible by the investigator/sub-investigator for any other reasons

<At the time of registration>
3) Subjects who recorded at least twice soft stool or watery stool (Bristol Stool Form Scale type 6 or 7) due to spontaneous evacuation of stool, during the 1-week observation period
4) Subjects who have fewer than 5 bowel movements during the 1-week observation period

Related Information

• Primary Sponsor: Manabe Noriaki
• Secondary Sponsor: EA Pharma Co., Ltd.,Mochida Pharmaceutical Co., Ltd.