A Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia (CONSIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pte Ltd
ClinicalTrials.gov Identifier:
NCT01880294
First received: June 14, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to evaluate the differences or similarities in the results obtained with two different scoring systems for chronic constipation in Asian participants consulting in gastroenterology clinics (the Asian Neurogastro-enterology and Motility Association (ANMA) chronic constipation (CC) diagnostic tool (diagnosis questionnaire) and the ROME III diagnosis criteria (western gold standard).


Condition Intervention Phase
Constipation
Drug: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: CONSIST- Constipation Symptoms Observational Study: A Multicenter, Cross-Sectional Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pte Ltd:

Primary Outcome Measures:
  • The percentage of participants for whom the chronic constipation (CC) diagnosis, according to the Asian Neurogastro-enterology and Motility Association (ANMA) CC diagnostic tool, agrees with the CC diagnosis according to the ROME III diagnosis criteria [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

    ANMA CC diagnostic criteria: hard stools; difficulty to pass stool; sensation of incomplete evacuation; less than 3 bowel movements per week; straining; sensation of anorectal obstruction; manual maneuvers; CC symptoms for the last 3 months with a symptom onset at least 3 months before diagnosis.

    ROME III CC diagnosis criteria (any 2 or more): straining; lumpy or hard stools; sensation of incomplete evacuation; sensation of anorectal obstruction; manual maneuvers; less than 3 bowel movements per week; CC symptoms for the last 3 months with a symptom onset at least 6 months before diagnosis.


  • The percentage of participants for whom the CC diagnosis, according to the ANMA CC diagnostic tool, disagrees with the CC diagnosis according to the ROME III diagnosis criteria [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage of participants with a diagnosis of CC according to the ROME III diagnosis criteria [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of participants with CC diagnosed by ROME III divided by the number of Asian participants screened (at the gastroenterologist clinic).

  • The percentage of participants with a diagnosis of CC according to the ANMA CC diagnostic tool [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of participants with CC diagnosed by ANMA divided by the number of Asian participants screened (at the gastroenterologist clinic).

  • The percentage of participants with a diagnosis of CC according to investigator judgement [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of participants with CC diagnosed by investigator's judgement divided by the number of Asian participants screened (at the gastroenterologist clinic).

  • The percentage of participants with participant self-defined CC [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of participants with self-defined CC divided by the number of Asian participants screened (at the gastroenterologist clinic).

  • The percentage of ROME-positive participants who need CC therapy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of participants with a positive ROME diagnosis who need CC therapy.

  • The percentage of ROME-negative but ANMA positive participants who need CC therapy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of participants with a negative ROME diagnosis but positive ANMA diagnosis who need CC therapy.

  • Participant assessment of current treatment as measured by the Constipation-Quality of Life (PAC-QOL) questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The PAC-QOL is a 28-item scale which includes 4 subscales: worries and concerns, physical discomfort, psychosocial discomfort, and satisfaction. Each item is rated on a 5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Total score ranges from 0 (best) to 112 (worst). Higher score indicates more impact on QOL.


Enrollment: 461
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Asian participants with chronic constipation
Asian participants diagnosed with chronic constipation using Asian Neurogastro-enterology and Motility Association (ANMA) diagnostic questionnaire.
Drug: No intervention
Asian participants diagnosed with chronic constipation using ANMA diagnostic questionnaire will be observed.

Detailed Description:

This is an observational (investigators observe participants and measure outcomes without assigning a treatment), non-product specific, regional multicenter (conducted at multiple sites) and multicountry, cross-sectional (observation of all members of a population at one specific point in time), epidemiological study (study of the patterns, causes, and effects of health and disease conditions in defined populations). The study will be conducted in 3 steps. In Step 1 (screening phase), all adult participants visiting their gastroenterologist (for any condition) within a 3 month period will be screened using the ANMA screening worksheet. In Step 2A (diagnosis phase - during investigator chosen consecutive consultation days), all the eligible participants will be required to complete a combination Diagnosis Questionnaire to obtain a diagnosis of CC based on different criteria: self-defined, investigator-judgement, ANMA tool, and ROME III criteria. Details about previous examinations and demography will also be collected during Step 2A of the study, together with Patient Assessment of Constipation Symptoms (PAC-SYM). Participants with a positive response to the ANMA diagnosis tool will proceed to Step 2B. In Step 2B (documentation phase), more information about the participant will be collected using the documentation questionnaire: demography, medical history, history of CC, current symptoms of CC, comorbidities, past and current medications for CC. The Patient Assessment of Constipation-Quality of Life (PAC-QOL) scale will be used to assess participant's satisfaction with their current treatment. Approximately 2000 participants will be screened to yield approximately 400 participants with suspected chronic constipation for whom the Diagnostic and Documentation Questionnaire will be filled in. Safety evaluations will include assessment of adverse events and special reporting situations such as pregnancy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Asian participants diagnosed with chronic constipation using the Asian Neurogastro-enterology and Motility Association diagnostic tool.

Criteria

Inclusion Criteria:

  • Participants who have at least 1 of the symptoms listed in the Screening Worksheet and the symptom has been present for at least 3 months
  • Participants have signed the informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to complete all the questions on the questionnaires

Exclusion Criteria:

  • Participants judged by the investigator to suffer from chronic constipation that is drug-induced or with secondary causes eg, endocrine, metabolic or neurological disorders, surgical obstruction, megacolon/megarectum, a diagnosis of pseudo-obstruction and organic disorders of the large bowel
  • Pregnant female participants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880294

Locations
China
Beijing, China
Guangzhou, China
Nanjing, China
Wuhan, China
Korea, Republic of
Daegu, Korea, Republic of
Iksan, Korea, Republic of
Seongnam-Si, Korea, Republic of
Seoul, Korea, Republic of
Malaysia
Georgetown, Malaysia
Kuala Lumpur, Malaysia
Philippines
Manila, Philippines
Quezon City, Philippines
San Juan, Philippines
Singapore
Singapore, Singapore
Sponsors and Collaborators
Johnson & Johnson Pte Ltd
Investigators
Study Director: Johnson & Johnson Pte Ltd Clinical Trial Johnson & Johnson Pte Ltd
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pte Ltd
ClinicalTrials.gov Identifier: NCT01880294     History of Changes
Other Study ID Numbers: CR100891, PRUCOP4003
Study First Received: June 14, 2013
Last Updated: February 7, 2014
Health Authority: Malaysia: National Pharmaceutical Control Bureau

Keywords provided by Johnson & Johnson Pte Ltd:
Constipation
Chronic constipation
Asia-Pacific
Gastroentrology
Asian participants

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014