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

NCT01902537 | Completed

• 2 other identifiers: CR100894PRUCRC4001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Constipation; Prucalopride

Outcome Measures

Primary Outcomes (6)

• EQ-5D-3L (EuroQol 5 Dimension 3 Level) Quality of life (QoL) Score at 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.

  Baseline

• EQ-5D-3L (EuroQol 5 Dimension) Quality of life (QoL) Score at 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.

  Week 1

• EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life (QoL) Score at 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.

  Baseline

• EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life (QoL) Score at 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

• Short Form 36 (SF-36) Quality of life (QoL) Score

  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).

  Baseline

• Participant Assessment of Constipation Quality of Life (PAC-QoL) Scale Score

  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.

  Baseline

Study Arms (1)

Participants With Constipation

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

Drug: Prucalopride; observational study

Interventions

Prucalopride; observational study 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.

Participants With Constipation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Korean female participants with chronic constipation having received treatment previously

You may not qualify if:

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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Constipation

Interventions

prucalopride; Observation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

KR (1)