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

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ClinicalTrials.gov Identifier: NCT01902537
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Brief Summary:
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.

Condition or disease Intervention/treatment
Constipation Drug: Prucalopride; observational study

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.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Health Related Quality of Life in Female Patients With Chronic Constipation
Study Start Date : August 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Group/Cohort Intervention/treatment
Participants With Constipation
Participants with constipation receiving prucalopride will be observed for for the health related quality of life (QoL).
Drug: 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.




Primary Outcome Measures :
  1. EQ-5D-3L (EuroQol 5 Dimension 3 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 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.

  2. EQ-5D-3L (EuroQol 5 Dimension) 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 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.

  3. 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.

  4. 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.

  5. Short Form 36 (SF-36) Quality of life (QoL) Score [ Time Frame: Baseline ]
    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).

  6. Participant Assessment of Constipation Quality of Life (PAC-QoL) Scale Score [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902537


Locations
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Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

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Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01902537     History of Changes
Other Study ID Numbers: CR100894
PRUCRC4001
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013
Keywords provided by Janssen Korea, Ltd., Korea:
Constipation
Prucalopride
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Prucalopride
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs