NCT02281630

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
388

participants targeted

Target at 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

Study Start

First participant enrolled

October 15, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2015

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

October 22, 2014

Last Update Submit

May 18, 2017

Conditions

Chronic Constipation

Keywords

Chronic ConstipationCC

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1

    1 week

Secondary Outcomes (12)

  • Complete SBM (CSBM) frequency and responder rate

    4 weeks

  • SBM frequency and responder rate

    4 weeks

  • Time to first SBM after the initial dose

    4 weeks

  • Stool consistency

    4 weeks

  • Degree of straining

    4 weeks

  • +7 more secondary outcomes

Study Arms (3)

KWA-0711 High dose

EXPERIMENTAL
Drug: KWA-0711

KWA-0711 Low dose

EXPERIMENTAL
Drug: KWA-0711

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KWA-0711DRUG
KWA-0711 High doseKWA-0711 Low dose
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 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)

Unknown Facility

Tokyo and Other Japanese City, Japan

Location

Related Publications (1)

  • Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25.

    PMID: 30056028DERIVED

Study Officials

  • Tatsuro Takei

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2014

First Posted

November 3, 2014

Study Start

October 15, 2014

Primary Completion

April 28, 2015

Last Updated

May 22, 2017

Record last verified: 2017-05

Locations

JP(1)