Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation

This study has been completed.
Sponsor:
Collaborator:
Tsumura USA
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital
ClinicalTrials.gov Identifier:
NCT00522093
First received: August 27, 2007
Last updated: August 21, 2011
Last verified: October 2009
  Purpose

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.


Condition Intervention
Chronic Constipation
Drug: TJ-100

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Showa Inan General Hospital:

Primary Outcome Measures:
  • Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events [ Time Frame: baseline (4 weeks) ] [ Designated as safety issue: Yes ]
  • Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: TJ-100
    TJ-100 2.5g three times per day for 6 weeks
  Eligibility

Ages Eligible for Study:   20 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522093

Locations
Japan
Showa Inan General Hospital
Komagane, Japan, 399-4191
Sponsors and Collaborators
Showa Inan General Hospital
Tsumura USA
Investigators
Principal Investigator: Akira Horiuchi, M.D. Showa Inan General Hospital
  More Information

No publications provided

Responsible Party: Akira Horiuchi, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT00522093     History of Changes
Other Study ID Numbers: TJ-100
Study First Received: August 27, 2007
Last Updated: August 21, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Showa Inan General Hospital:
constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014