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

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ClinicalTrials.gov Identifier: NCT00522093
Recruitment Status : Completed
First Posted : August 29, 2007
Last Update Posted : August 23, 2011
Sponsor:
Collaborator:
Tsumura USA
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: TJ-100 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation


Intervention Details:
  • Drug: TJ-100
    TJ-100 2.5g three times per day for 6 weeks


Primary Outcome Measures :
  1. Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events [ Time Frame: baseline (4 weeks) ]
  2. Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events [ Time Frame: 6 weeks ]
  3. Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Akira Horiuchi, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT00522093     History of Changes
Other Study ID Numbers: TJ-100
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: October 2009

Keywords provided by Akira Horiuchi, Showa Inan General Hospital:
constipation

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