NCT01600001

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

First QC Date

May 14, 2012

Last Update Submit

October 29, 2013

Conditions

Chronic Idiopathic Constipation

Keywords

Chronic Idiopathic Constipation (CIC)ConstipationFunctional gastrointestinal disorders

Outcome Measures

Primary Outcomes (1)

  • Improvement of signs and symptoms associated with constipation

    4 weeks

Study Arms (5)

Drug:KWA-0711 dose 1

EXPERIMENTAL
Drug: KWA-0711

Drug:KWA-0711 dose 2

EXPERIMENTAL
Drug: KWA-0711

Drug:KWA-0711 dose 3

EXPERIMENTAL
Drug: KWA-0711

Drug:KWA-0711 dose 4

EXPERIMENTAL
Drug: KWA-0711

Drug: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KWA-0711DRUG
Drug:KWA-0711 dose 1Drug:KWA-0711 dose 2Drug:KWA-0711 dose 3Drug:KWA-0711 dose 4
PlaceboDRUG
Drug: Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment
  • The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation

You may not qualify if:

  • Patients who have secondary constipation caused by systemic disorder
  • Patients who have organic constipation
  • Patients who received intestinal resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Tokyo and Other Japanese City, Japan

Location

MeSH Terms

Conditions

ConstipationGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

JP(1)