Effect of TU-100 in Patients With Functional Constipation

This study has been completed.
Sponsor:
Collaborator:
Cato Research
Information provided by (Responsible Party):
Tsumura USA
ClinicalTrials.gov Identifier:
NCT01348152
First received: May 3, 2011
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

The primary objective of this study is to evaluate the improvement in the severity of constipation (from Baseline to Day 28), determined by the constipation severity instrument (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100 administered for 28 consecutive days in adult subjects with functional constipation.


Condition Intervention Phase
Functional Constipation
Drug: DAIKENCHUTO (TU-100)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Exploratory Study of Daikenchuto (TU-100) in Patients With Functional Constipation

Resource links provided by NLM:


Further study details as provided by Tsumura USA:

Primary Outcome Measures:
  • Change from baseline to Day 28 in CSI total score [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in GI transit time measured by SmartPill capsule. [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Day 28 in CRQOL total score. [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in stool frequency, stool consistency, severity of straining, and completeness of evacuation determined from entries in the bowel pattern diary. [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Day 28 in CSI subscale scores. [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Day 28 in CRQOL subscale scores. [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo TID
Drug: Placebo
Subjects will be randomized to 15 g/day of placebo. Dosage is granule. Subjects will ingest two 2.5 g doses of placebo three times daily for 34 consecutive days.
Experimental: DAIKENCHUTO (TU-100) 15 g/day
TU-100 5g TID
Drug: DAIKENCHUTO (TU-100)
Subjects will be randomized to 15 g/day of TU-100. Dosage is granule. Subjects will ingest two 2.5 g doses of TU-100 three times daily for 34 consecutive days.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have severity of constipation in CSI score of 25 to 74 points.
  2. Have the ability to orally ingest study medication, TU-100, and the SmartPill capsule.
  3. Be male or female aged between 18 and 80 years old, inclusive.
  4. Provide written informed consent before participation in the study after full explanations of the study purpose and procedures.
  5. If a female is of childbearing potential and sexually active:

    1. She must agree to practice a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, during their participation in the trial and for 4 weeks after receiving the last dose of study drug
    2. She must have a negative serum pregnancy test before randomization.
  6. If a male is sexually active with a female of childbearing potential:

    1. He must agree to use a double barrier of birth control during the study and for 4 weeks after receiving the last dose of study drug.
    2. He must not donate sperm during the study and for 4 weeks after receiving the last dose of study drug.

Exclusion Criteria:

  1. Presence of strictures, fistulas, or physiological or mechanical bowel obstruction.
  2. Presence of implanted or portable electro-mechanical medical devices.
  3. History of gastric bezoar or swallowing disorders.
  4. History of gastrointestinal surgery within 3 months of screening.
  5. History of bowel resection.
  6. Current pregnancy or lactation.
  7. History of clinically significant alcohol or drug abuse within a year of screening.
  8. Have any other condition that might adversely affect capacity to participate in this study, including liver disorders (with serum alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels exceeding 2.5 times the upper limit of normal [ULN]), kidney disorders, heart failure, blood disorders, or metabolic disorders.
  9. Be diagnosed with cancer, ulcerative colitis, Crohn's disease, diverticulitis, scleroderma, Hirschsprung's disease, Chagas' disease, multiple sclerosis, Parkinson's disease, stroke, paraplegia, quadriplegia, insulin-dependent diabetes mellitus, untreated hypothyroidism, or any other systemic or psychiatric disorder which may, in the opinion of the investigator, interfere with the evaluation of TU-100.
  10. Be taking any medication as follows: anticholinergic agents/medications with anticholinergic effect (list of prohibited drugs attached in Appendix G; antidepressants are permissible if the patient's symptoms are stable, and the doses are NOT changed during the course of the study), warfarin, prokinetics (i.e., Domperidone, Metoclopramide), narcotic analgesics, or any agent that might interfere with the evaluation of TU-100 in the opinion of the investigator.
  11. Have a history of allergic reaction or hypersensitivity to ginseng, ginger, and Sichuan pepper.
  12. Have severe dysphagia to food or pills.
  13. Have participated in any other clinical study within 30 days before enrolling in this study.
  14. Be unsuitable for participation in this trial for any reason, according to the investigator.
  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: NCT01348152

Locations
United States, Minnesota
Colon and Rectal Surgery Associates
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Tsumura USA
Cato Research
Investigators
Principal Investigator: Anders F Mellgren, MD, PhD Colon and Rectal Surgery Associates
  More Information

No publications provided

Responsible Party: Tsumura USA
ClinicalTrials.gov Identifier: NCT01348152     History of Changes
Other Study ID Numbers: TU100CPT3
Study First Received: May 3, 2011
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Tsumura USA:
Gastric Emptying

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

ClinicalTrials.gov processed this record on October 22, 2014