Clinical trial NCT01880294: A Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia
Official title: CONSIST- Constipation Symptoms Observational Study: A Multicenter, Cross-Sectional Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Keywords: Constipation
Chronic constipation
Asia-Pacific
Gastroentrology
Asian participants
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-06-18
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian participants diagnosed with chronic constipation using the Asian Neurogastro-enterology and Motility Association diagnostic tool.

Brief summary: 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).

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 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

Primary outcomes:
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
Secondary outcomes:
measure: The percentage of participants with a diagnosis of CC according to the ROME III diagnosis criteria
timeFrame: Day 1
measure: The percentage of participants with a diagnosis of CC according to the ANMA CC diagnostic tool
timeFrame: Day 1
measure: The percentage of participants with a diagnosis of CC according to investigator judgement
timeFrame: Day 1
measure: The percentage of participants with participant self-defined CC
timeFrame: Day 1
measure: The percentage of ROME-positive participants who need CC therapy
timeFrame: Day 1
measure: The percentage of ROME-negative but ANMA positive participants who need CC therapy
timeFrame: Day 1
measure: Participant assessment of current treatment as measured by the Constipation-Quality of Life (PAC-QOL) questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Beijing
country: China
city: Guangzhou
country: China
city: Nanjing
country: China
city: Wuhan
country: China
city: Daegu
country: Korea, Republic of
city: Iksan
country: Korea, Republic of
city: Seongnam-Si
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Georgetown
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Manila
country: Philippines
city: Quezon City
country: Philippines
city: San Juan
country: Philippines
city: Singapore
country: Singapore
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: