The exploratory, multicenter, open-label study to evaluate the effect of linaclotide on the Japanese version of Patient Assessment of Constipation of Quality of Life Scale (JPAC-QOL) in patients whose QOL scale is poor in spite of taking magnesium oxide with adult chronic constipation

JRCT ID: jRCTs031200048

Registered date:09/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult patients with CC or IBS-C whose primary treatment of MgO was insufficiently effective
• Date of first enrollment: 01/07/2020
• Target sample size: 64
• Study type: Interventional
• Intervention(s): Patients take 0.5 mg of linaclotide once daily (Two tablets of Linzess tablets 0.25 mg, orally administered before meals) for 12 weeks.

Outcome(s)

• Primary Outcome: Change in JPAC-QOL score from baseline at 12 weeks of administration.

Secondary Outcome

1. Change in weekly average of SBM (weekly, treatment period).
2. Percentage of subjects with SBM within 24 hours of first dose.
3. Time to first SBM.
4. Change in weekly average of CSBM frequency (weekly, treatment period).
5. Percentage of subjects with CSBM within 24 hours of first dose.
6. Change in weekly mean of Bristol scale (weekly, treatment period).
7. Change in weekly average value of abdominal bloating severity score (weekly, treatment period).
8. Change in weekly average of severity score for abdominal pain / discomfort (weekly, treatment period).
9. Change in weekly average of severity score for straining (weekly, treatment period).
10. Change in JPAC-QOL total score, and subscale score.
11. Change in summary score and subscale of SF-12v2.
12. Satisfaction score for defecation.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1. Patients with written informed consent.
2. Patients diagnosed with choronic constipation (CC) or constipation-predominant irritable bowel syndrome (IBS-C) based on Rome IV criteria and prescribed 0.99-2g of magnesium oxide per day as a first-line drug for 4 weeks or more.
3. Outpatients whose ages are between 20 and 85 years old at the time of obtaining consent.
4. For female patients, patients who meet any of the following conditions.
Patients who are not likely to become pregnant are any of the following;Patients who have menopause at the time of enrollment (without menses for more than 1 year).Patients who have undergone surgical procedures (hysterectomy, ovariectomy, contraceptive surgery, etc.) and are judged to be unlikely to become pregnant by the researcher.
Patients who are likely to become pregnant are as follows; Patients who agreed not to become pregnant during the study period and 4 weeks after taking the drugs.

Exclude criteria

1. Patients with a history of surgical resection of the stomach, gallbladder, small intestine, or large intestine (except for appendicitis and polypectomy of benign polyps).
2. Patients with a history of, or currently suffering from, inflammatory bowel disease (Crohn's disease or ulcerative colitis)
3. Patients with, or currently have, ischemic colitis.
4. Patients currently suffering from infectious enteritis.
5. Patients currently suffering from hyperthyroidism or hypothyroidism.
6. Patients with mechanical bowel obstruction (due to hernia, etc.).
7. Patients with megacolon or megarectum.
8. Patients currently suffering from constipation due to anorectal dysfunction.
9. Patients currently suffering from constipation due to drugs.
10. Patients currently suffering from constipation due to organic diseases.
11. Patients currently suffering from active peptic ulcer.
12. Patients with severe depression or anxiety symptoms who are judged to affect the efficacy evaluation.
13. Patients who have had or are currently abusing drugs or alcohol within one year before obtaining consent.
14. Patients who have used or are planning to use any of the following prohibited drugs in the past.
Lubiprostone, Elobixibat, Polyethylene glycol, Lactulose
15. Patients who have prescribed or are planning to prescribe antiparkinson, antipsychotic, antimanic or psychostimulant drugs at the time of registration.
16. Patients who have performed or are planning to perform the following prohibited tests 3 days before the registration date.
Colonoscopy, Gastrointestinal scopy
17. Patients who have had, or currently have, a gastrointestinal cancer, excluding gastrointestinal cancer cured by endoscopic treatment
18. Patients currently suffering from severe cardiovascular, respiratory, renal, hepatic, gastrointestinal (excluding chronic constipation), hematological or neurological / psychiatric disorders.
19. Patients with a history of drug allergy.
20. Patients who have participated in or are currently participating in clinical trials, post-marketing clinical trials, clinical studies of other drugs or medical devices within 12 weeks before obtaining consent.
21. Patients who are considered inappropriate to participate in this study by the reseacher.

Related Information

• Primary Sponsor: Misawa Noboru
• Secondary Sponsor: Yoshihara Tsutomu,Astellas Pharma Inc.