A Randomized, Double-Blinded, Placebo-Controlled Exploratory Study of Daikenchuto (TU-100) in Patients With Functional Constipation

Tsumura USA1 site in 1 country50 target enrollmentSeptember 2011

ConditionsFunctional Constipation

InterventionsPlacebo DAIKENCHUTO (TU-100)

DrugsDAIKENCHUTO (TU-100)Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Functional Constipation
Sponsor: Tsumura USA
Enrollment: 50
Locations: 1
Primary Endpoint: Change from baseline to Day 28 in CSI total score
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

July 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tsumura USA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have severity of constipation in CSI score of 25 to 74 points.
•Have the ability to orally ingest study medication, TU-100, and the SmartPill capsule.
•Be male or female aged between 18 and 80 years old, inclusive.
•Provide written informed consent before participation in the study after full explanations of the study purpose and procedures.
•If a female is of childbearing potential and sexually active:
•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
•She must have a negative serum pregnancy test before randomization.
•If a male is sexually active with a female of childbearing potential:
•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.
•He must not donate sperm during the study and for 4 weeks after receiving the last dose of study drug.

Exclusion Criteria

•Presence of strictures, fistulas, or physiological or mechanical bowel obstruction.
•Presence of implanted or portable electro-mechanical medical devices.
•History of gastric bezoar or swallowing disorders.
•History of gastrointestinal surgery within 3 months of screening.
•History of bowel resection.
•Current pregnancy or lactation.
•History of clinically significant alcohol or drug abuse within a year of screening.
•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.
•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-
•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.

Arms & Interventions

Placebo

Placebo TID

Intervention: Placebo

DAIKENCHUTO (TU-100) 15 g/day

TU-100 5g TID

Intervention: DAIKENCHUTO (TU-100)

Outcomes

Primary Outcomes

Change from baseline to Day 28 in CSI total score

Time Frame: Up to 10 weeks

Secondary Outcomes

Change from baseline in GI transit time measured by SmartPill capsule.(Up to 10 weeks)
Change from baseline to Day 28 in CRQOL total score.(Up to 10 weeks)
Changes from baseline in stool frequency, stool consistency, severity of straining, and completeness of evacuation determined from entries in the bowel pattern diary.(Up to 10 weeks)
Change from baseline to Day 28 in CSI subscale scores.(Up to 10 weeks)
Change from baseline to Day 28 in CRQOL subscale scores.(Up to 10 weeks)