A study to reveal the actual clinical features of chronic constipation and to evaluate the efficacy of therapeutic drugs on chronic constipation

A study to reveal the actual clinical features of chronic constipation and to evaluate the efficacy of therapeutic drugs on chronic constipation - A study to reveal the actual clinical features of chronic constipation and to evaluate the efficacy of therapeutic drugs on chronic constipation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035794

Enrollment

800

Registered

2019-02-13

Start date

2019-05-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic constipation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Moderate or severe chronic constipation (2) Age over 20 years old, any sex (3) Spontaneous agreement of the said person (4) Capable to understand the questionnaire

Exclusion criteria

Exclusion criteria: (1) Alarm feature such as vomiting, gastrointestinal tract bleeding, (includes hematemesis, bloody stool, anemia, etc.) or rapid weight loss (2) History of gastrointestinal tract resection or vagotomy (3) Any other disease or previous surgery which may influence the results of questionnaire more than chronic constipation (4) Any organ failure or mental disease (5) Confirmed or suspected malignancy (6) Pregnancy, possible pregnancy, or breastfeeding (7) Judged as irrelevant by the responsible doctor of this study

Design outcomes

Primary

Measure	Time frame
The actual clinical features of chronic constipation explored by several questionnaires such as CC-TEST, Constipation Scoring System (CSS), Hospital Anxiety and Depression Scale (HADS), and Short Form-8 (SF-8). The efficacy of the therapeutic drugs on chronic constipation. The reliability and validity of the newly developed questionnaire for chronic constipation, CC-TEST. Outcome measures evaluation using questionnaires were performed at baseline, at 2 weeks and at 4 weeks after medication.	—

Measure

Time frame

The actual clinical features of chronic constipation explored by several questionnaires such as CC-TEST, Constipation Scoring System (CSS), Hospital Anxiety and Depression Scale (HADS), and Short Form-8 (SF-8). The efficacy of the therapeutic drugs on chronic constipation. The reliability and validity of the newly developed questionnaire for chronic constipation, CC-TEST. Outcome measures evaluation using questionnaires were performed at baseline, at 2 weeks and at 4 weeks after medication.

—

Secondary

Measure	Time frame
The effect of each constipation symptoms on patients' dairy life. Comparison of the efficacy of therapeutic drugs on chronic constipation among the groups divided by their mechanism of action. The relationship between the patients' background factors and the clinical features of chronic constipation.	—

Countries

Japan

Contacts

Public ContactKoji Nakada

The Jikei University Daisan Hospital Department of Laboratory Medicine

nakada@jikei.ac.jp03-3480-1151

Outcome results