ConstipationCONSISTNCT01880294
A Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia
An observational study of Constipation, run by Janssen Research & Development, LLC at 14 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- How many people
- 461 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 18 Mar 2013to 14 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asian participants diagnosed with chronic constipation using the Asian Neurogastro-enterology and Motility Association diagnostic tool.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
China4 sites
Study site
Beijing
Study site
Guangzhou
Study site
Nanjing
Study site
Wuhan
South Korea4 sites
Study site
Daegu
Study site
Iksan
Study site
Seongnam-si
Study site
Seoul
Philippines3 sites
Study site
Manila
Study site
Quezon City
Study site
San Juan City
About this study
Official title: CONSIST- Constipation Symptoms Observational Study: A Multicenter, Cross-Sectional Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia
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).
Read the 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
- Being tested
- No intervention
- Keywords
- Constipation, Chronic constipation, Asia-Pacific, Gastroentrology, Asian participants
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
Asian participants diagnosed with chronic constipation using ANMA diagnostic questionnaire will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Asian participants with chronic constipation | Asian participants diagnosed with chronic constipation using Asian Neurogastro-enterology and Motility Association (ANMA) diagnostic questionnaire. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Day 1
Secondary outcomes (7)
The percentage of participants with a diagnosis of CC according to the ROME III diagnosis criteria
Number of participants with CC diagnosed by ROME III divided by the number of Asian participants screened (at the gastroenterologist clinic).
Measured: Day 1
The percentage of participants with a diagnosis of CC according to the ANMA CC diagnostic tool
Number of participants with CC diagnosed by ANMA divided by the number of Asian participants screened (at the gastroenterologist clinic).
Measured: Day 1
The percentage of participants with a diagnosis of CC according to investigator judgement
Number of participants with CC diagnosed by investigator's judgement divided by the number of Asian participants screened (at the gastroenterologist clinic).
Measured: Day 1
The percentage of participants with participant self-defined CC
Number of participants with self-defined CC divided by the number of Asian participants screened (at the gastroenterologist clinic).
Measured: Day 1
The percentage of ROME-positive participants who need CC therapy
Number of participants with a positive ROME diagnosis who need CC therapy.
Measured: Day 1
The percentage of ROME-negative but ANMA positive participants who need CC therapy
Number of participants with a negative ROME diagnosis but positive ANMA diagnosis who need CC therapy.
Measured: Day 1
Participant assessment of current treatment as measured by the Constipation-Quality of Life (PAC-QOL) questionnaire
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study start18 Mar 2013
- Primary completion14 Dec 2013
- Study completion14 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880294
- Sponsor's protocol ID
- CR100891
- Other IDs
- PRUCOP4003
- Acronym
- CONSIST
- Status last verified
- Oct 2024
- First submitted
- 14 Jun 2013
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONSIST- Constipation Symptoms Observational Study: A Multicenter, Cross-Sectional Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia
- ClinicalTrials.gov ID
- NCT01880294
- Acronym / sponsor ID
- CONSIST / CR100891
- Conditions
- Constipation
- Keywords
- Constipation, Chronic constipation, Asia-Pacific, Gastroentrology, Asian participants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2013 (actual)
- Primary completion
- 14 Dec 2013 (actual)
- Study completion
- 14 Dec 2013 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asian participants with chronic constipation | – | Drug: No interventionAsian participants diagnosed with chronic constipation using Asian Neurogastro-enterology and Motility Association (ANMA) diagnostic questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asian participants diagnosed with chronic constipation using the Asian Neurogastro-enterology and Motility Association diagnostic tool.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAsian participants diagnosed with chronic constipation using ANMA diagnostic questionnaire will be observed. | Drug | Asian participants with chronic constipation |
Primary outcome
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
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
7 secondary outcomes
The percentage of participants with a diagnosis of CC according to the ROME III diagnosis criteria
Time frame: Day 1
The percentage of participants with a diagnosis of CC according to the ANMA CC diagnostic tool
Time frame: Day 1
The percentage of participants with a diagnosis of CC according to investigator judgement
Time frame: Day 1
The percentage of participants with participant self-defined CC
Time frame: Day 1
The percentage of ROME-positive participants who need CC therapy
Time frame: Day 1
The percentage of ROME-negative but ANMA positive participants who need CC therapy
Time frame: Day 1
Participant assessment of current treatment as measured by the Constipation-Quality of Life (PAC-QOL) questionnaire
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by Janssen Research & Development, LLC at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China, South Korea, Philippines, Malaysia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.