Text Size

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
History of Changes

August 27, 2007
August 21, 2011
August 2007
March 2008   (final data collection date for primary outcome measure)
  • 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 ]
Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events [ Time Frame: baseline (4 weeks), 6 weeks and 2 weeks ]
Complete list of historical versions of study NCT00522093 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation
Not Provided

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Constipation
Drug: TJ-100
TJ-100 2.5g three times per day for 6 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00522093
TJ-100
Yes
Akira Horiuchi, Showa Inan General Hospital
Showa Inan General Hospital
Tsumura USA
Principal Investigator: Akira Horiuchi, M.D. Showa Inan General Hospital
Showa Inan General Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP