A Exploratory Study of KWA-0711 in Patients With Chronic... | NCT01600001

Studies
A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

NCT01600001

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Oct 30, 2013Estimated

Enrollment

75Estimated

Phase

Phase 2

Conditions

Chronic Idiopathic 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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 14, 2012

First Submission Date that Met QC Criteria

May 15, 2012

First Posted Date

May 16, 2012Estimated

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

Oct 29, 2013

Last Update Posted Date

Oct 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
KWA-0711	Drug		Drug:KWA-0711 dose 1 Drug:KWA-0711 dose 2 Drug:KWA-0711 dose 3 Drug:KWA-0711 dose 4

Measure	Description	Time Frame
Improvement of signs and symptoms associated with constipation		4 weeks

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

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

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation
D005767	Gastrointestinal Diseases

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided