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

NCT01880294 | Completed

• 2 other identifiers: CR100891PRUCOP4003
• Study Type: observational
• Target: 461
• Locations: 5 countries
• Sites: 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).

Conditions

Constipation

Keywords

Constipation; Chronic constipation; Asia-Pacific; Gastroentrology; Asian participants

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Day 1

• 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

  Day 1

Secondary Outcomes (7)

• The percentage of participants with a diagnosis of CC according to the ROME III diagnosis criteria

  Day 1

• The percentage of participants with a diagnosis of CC according to the ANMA CC diagnostic tool

  Day 1

• The percentage of participants with a diagnosis of CC according to investigator judgement

  Day 1

• The percentage of participants with participant self-defined CC

  Day 1

• The percentage of ROME-positive participants who need CC therapy

  Day 1

Study Arms (1)

Asian participants with chronic constipation

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

Drug: No intervention

Interventions

No intervention DRUG

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

Asian participants with chronic constipation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (14)

Unknown Facility

Beijing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Wuhan, China

Location

Unknown Facility

George Town, Malaysia

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Manila, Philippines

Location

Unknown Facility

Quezon City, Philippines

Location

Unknown Facility

San Juan City, Philippines

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Iksan, South Korea

Location

Unknown Facility

Seongnam-si, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  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: June 14, 2013
• First Posted: June 18, 2013
• Study Start: March 18, 2013
• Primary Completion: December 14, 2013
• Study Completion: December 14, 2013
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

PH (3); CN (4); MY (2); KR (4); SG (1)