Back to resultsEfficacy and Safety of TJ-100 in the Treatment of Chronic Constipation
Primary Purpose
Chronic Constipation
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
TJ-100
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Constipation focused on measuring constipation
Eligibility Criteria
Inclusion Criteria:
- chronic constipation defined as less than 3 spontaneous bowel movement frequencies per week
- had symptoms of abdominal bloating or discomfort
Exclusion Criteria:
- mechanical bowel obstruction
- clinically systemic disease-induced constipation
- pregnancy
Sites / Locations
- Showa Inan General Hospital
Outcomes
Primary Outcome Measures
Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT00522093
First Posted
August 27, 2007
Last Updated
August 21, 2011
Sponsor
Showa Inan General Hospital
Collaborators
Tsumura USA
1. Study Identification
Unique Protocol Identification Number
NCT00522093
Brief Title
Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital
Collaborators
Tsumura USA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may activate bowel movement. This study will test the efficacy and safety of TJ-100 in the treatment of patients with chronic constipation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TJ-100
Intervention Description
TJ-100 2.5g three times per day for 6 weeks
Primary Outcome Measure Information:
Title
Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
Time Frame
baseline (4 weeks)
Title
Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
Time Frame
6 weeks
Title
Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic constipation defined as less than 3 spontaneous bowel movement frequencies per week
had symptoms of abdominal bloating or discomfort
Exclusion Criteria:
mechanical bowel obstruction
clinically systemic disease-induced constipation
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akira Horiuchi, M.D.
Organizational Affiliation
Showa Inan General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Showa Inan General Hospital
City
Komagane
ZIP/Postal Code
399-4191
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation
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