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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014