NCT00522093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 23, 2011

Status Verified

October 1, 2009

Enrollment Period

7 months

First QC Date

August 27, 2007

Last Update Submit

August 21, 2011

Conditions

Chronic Constipation

Keywords

constipation

Outcome Measures

Primary Outcomes (3)

  • Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events

    baseline (4 weeks)

  • Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events

    6 weeks

  • Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events

    2 weeks

Interventions

TJ-100DRUG

TJ-100 2.5g three times per day for 6 weeks

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic constipation defined as less than 3 spontaneous bowel movement frequencies per week
  • had symptoms of abdominal bloating or discomfort

You may not qualify if:

  • mechanical bowel obstruction
  • clinically systemic disease-induced constipation
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General Hospital

Komagane, 399-4191, Japan

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Akira Horiuchi, M.D.

    Showa Inan General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Digestive Disease Center

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 29, 2007

Study Start

August 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

August 23, 2011

Record last verified: 2009-10

Locations

JP(1)