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

This study has been completed.

First Received on August 27, 2007. Last Updated on August 21, 2011 History of Changes

Sponsor:	Showa Inan General Hospital
Collaborator:	Tsumura USA
Information provided by (Responsible Party):	Akira Horiuchi, Showa Inan General Hospital
ClinicalTrials.gov Identifier:	NCT00522093

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:

MedlinePlus related topics: Bowel Movement Constipation Gas

Drug Information available for: TJ 100

U.S. FDA Resources

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:

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 February 09, 2012