- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01902537
An Observational Study to Evaluate the Quality of Life in Korean Female Participants With Chronic Constipation
July 15, 2013 updated by: Janssen Korea, Ltd., Korea
Health Related Quality of Life in Female Patients With Chronic Constipation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Korean female participants with chronic constipation, having received treatment previously for constipation.
Participants who have visited Constipation Clinic of AMC or Department of Gastrointestinal for constipation therapy will be selected.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants With Constipation
Participants with constipation receiving prucalopride will be observed for for the health related quality of life (QoL).
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This is an observational study.
Korean female participants with chronic constipation and having received treatment previously will be assessed for the health related QoL.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EQ-5D-3L (EuroQol 5 Dimension 3 Level) Quality of life (QoL) Score at Baseline
Time Frame: Baseline
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The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 3 levels; 1 indicates better health state (no problems); 3 indicate worst health state ("confined to bed").
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
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Baseline
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EQ-5D-3L (EuroQol 5 Dimension) Quality of life (QoL) Score at Week 1
Time Frame: Week 1
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The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 3 levels; 1 indicates better health state (no problems); 3 indicate worst health state ("confined to bed").
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
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Week 1
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EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life (QoL) Score at Baseline
Time Frame: Baseline
|
The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems).
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and possible total score range -0.654 to 1.000; higher score indicates a better health state.
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Baseline
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EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life (QoL) Score at Week 1
Time Frame: Week 1
|
The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems).
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and possible total score range -0.654 to 1.000; higher score indicates a better health state.
|
Week 1
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Short Form 36 (SF-36) Quality of life (QoL) Score
Time Frame: Baseline
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The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
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Baseline
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Participant Assessment of Constipation Quality of Life (PAC-QoL) Scale Score
Time Frame: Baseline
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The PAC-QOL is composed of 28 items grouped into four subscales related to dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items).
Participants rated the severity of each symptom on a five-point scale from 0 (absent) to 4 (very severe), and scores are reported as an average total score or subscale score.
The overall and all subscale scores range from 0 to 4, with lower scores indicating better health-related quality of life.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
July 15, 2013
First Submitted That Met QC Criteria
July 15, 2013
First Posted (Estimate)
July 18, 2013
Study Record Updates
Last Update Posted (Estimate)
July 18, 2013
Last Update Submitted That Met QC Criteria
July 15, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100894
- PRUCRC4001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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