Phase II Dose-Finding Study of KWA-0711 in Patients With... | NCT02281630

Studies
Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)

NCT02281630

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

May 22, 2017Actual

Enrollment

388Actual

Phase

Phase 2

Conditions

Chronic Constipation

Interventions

KWA-0711
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2014Actual

Primary Completion Date

Apr 28, 2015Actual

Completion Date

Not provided

First Submitted Date

Oct 22, 2014

First Submission Date that Met QC Criteria

Oct 30, 2014

First Posted Date

Nov 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2017

Last Update Posted Date

May 22, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

388Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
KWA-0711 High dose	Experimental	Drug: KWA-0711
KWA-0711 Low dose	Experimental	Drug: KWA-0711
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KWA-0711	Drug		KWA-0711 High dose KWA-0711 Low dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1		1 week

Secondary Outcomes

Measure	Description	Time Frame
Complete SBM (CSBM) frequency and responder rate		4 weeks
SBM frequency and responder rate		4 weeks
Time to first SBM after the initial dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tatsuro Takei	Kissei Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Tokyo and Other Japanese City			Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30056028	Derived	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.

Type	Date	Date Unknown
Release	Dec 11, 2019
Reset	Dec 31, 2019