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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Constipation

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01880294

CR100891

PRUCOP4003 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 461 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

461 participants in 1 patient group

Asian participants with chronic constipation

Description:

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

Treatment:

Drug: No intervention