NCT02514057

Brief Summary

Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2020

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
5.3 years until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

2 days

First QC Date

July 31, 2015

Last Update Submit

April 28, 2021

Conditions

Those With and Without Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

  • Construct validity measured by Validation of new score

    Validation of new score

    18 months

Study Arms (3)

Healthy

Volunteers over 18 years

Other: Questionnaire

Gastrointestinal disorders

Over 18 and with any gastrointestinal or liver disorder

Other: Questionnaire

Non-gastrointestinal disorders

Over 18 and with any medical condition requiring hospital attention in which there is no primary gastrointestinal or liver disease

Other: Questionnaire

Interventions

QuestionnaireOTHER

Form filling only

Gastrointestinal disordersHealthyNon-gastrointestinal disorders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As above

You may qualify if:

  • As above Either healthy or GI disease or non-GI disease

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alastair Forbes, MD

    UEA

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 3, 2015

Study Start

November 1, 2020

Primary Completion

November 3, 2020

Study Completion

November 3, 2020

Last Updated

May 4, 2021

Record last verified: 2021-04