NCT01938196

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in chronic constipation patients.

Trial Health

80
On Track

Trial Health Score

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

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

August 27, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

First QC Date

August 27, 2013

Last Update Submit

November 11, 2014

Conditions

Chronic Constipation

Keywords

Chronic ConstipationConstipationFunctional gastrointestinal disorders

Outcome Measures

Primary Outcomes (1)

  • Improvement of signs and symptoms associated with constipation

    * Frequency of Spontaneous Bowel Movements * Bowel Movement Timing * Stool Consistency * Abdominal Assessment * QOL Assessment

    5 weeks

Study Arms (5)

KWA-0711 Dose1

EXPERIMENTAL
Drug: KWA-0711

KWA-0711 Dose2

EXPERIMENTAL
Drug: KWA-0711

KWA-0711 Dose3

EXPERIMENTAL
Drug: KWA-0711

KWA-0711 Dose4

EXPERIMENTAL
Drug: KWA-0711

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KWA-0711DRUG
KWA-0711 Dose1KWA-0711 Dose2KWA-0711 Dose3KWA-0711 Dose4
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • The patients who experienced fewer than three spontaneous bowel movements 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)

Unknown Facility

Tokyo, 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 10, 2013

Primary Completion

January 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

JP(1)