We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522093
First Posted: August 29, 2007
Last Update Posted: August 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tsumura USA
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Akira Horiuchi, 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) ]
  • Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events [ Time Frame: 6 weeks ]
  • Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events [ Time Frame: 2 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 89 Years   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

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 Submitted: August 27, 2007
First Posted: August 29, 2007
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