An Observational Study to Evaluate the Quality of Life in Korean Female Participants With Chronic Constipation

NCT ID: NCT01902537

Last Updated: 2013-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this observational study is to investigate health related quality of life (QoL) in Korean female participants with chronic constipation (long term decreased number of or difficulty making bowel movements) having received treatment previously.

Detailed Description

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This is a cross-sectional (studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at 1 particular time) observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) to investigate the health related QoL in Korean female participants with chronic constipation having received treatment previously by using EQ-5D (EuroQol 5 Dimension), SF-36 (Short Form Health Survey) and PAC-QoL (Patient Assessment of Constipation) questionnaires. The duration of study will be 6 months. Participant's safety will be monitored throughout the study.

Conditions

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Constipation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants With Constipation

Participants with constipation receiving prucalopride will be observed for for the health related quality of life (QoL).

Prucalopride; observational study

Intervention Type DRUG

This is an observational study. Korean female participants with chronic constipation and having received treatment previously will be assessed for the health related QoL.

Interventions

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Prucalopride; observational study

This is an observational study. Korean female participants with chronic constipation and having received treatment previously will be assessed for the health related QoL.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Korean female participants with chronic constipation having received treatment previously

Exclusion Criteria

* Male participants
* Participants with psychological disease (disorders of the mind, thoughts, and behavior)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Locations

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Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PRUCRC4001

Identifier Type: -

Identifier Source: secondary_id

CR100894

Identifier Type: -

Identifier Source: org_study_id

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