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

NCT ID: NCT01880294

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 461 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-18
• Study Completion Date: 2013-12-14

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.

Conditions

Constipation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Asian participants with chronic constipation

Asian participants diagnosed with chronic constipation using Asian Neurogastro-enterology and Motility Association (ANMA) diagnostic questionnaire.

No intervention

Intervention Type: DRUG

Asian participants diagnosed with chronic constipation using ANMA diagnostic questionnaire will be observed.

Interventions

No intervention

Asian participants diagnosed with chronic constipation using ANMA diagnostic questionnaire will be observed.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Beijing, , China

Guangzhou, , China

Nanjing, , China

Wuhan, , China

George Town, , Malaysia

Kuala Lumpur, , Malaysia

Manila, , Philippines

Quezon City, , Philippines

San Juan City, , Philippines

Singapore, , Singapore

Daegu, , South Korea

Iksan, , South Korea

Seongnam-si, , South Korea

Seoul, , South Korea

Countries

China; Malaysia; Philippines; Singapore; South Korea

Other Identifiers

PRUCOP4003

Identifier Type: OTHER

Identifier Source: secondary_id

CR100891

Identifier Type: -

Identifier Source: org_study_id