Gastrointestinal Symptom Questionnaire Validation | NCT02514057

Studies
Gastrointestinal Symptom Questionnaire Validation

NCT02514057

Sponsor

University of East Anglia

Status

Withdrawn

Last Update Posted

May 4, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Those With and Without Gastrointestinal Disorders

Interventions

Questionnaire

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

investigator emigrated

Expanded Access Info

Start Date

Nov 2020Estimated

Primary Completion Date

Nov 3, 2020Actual

Completion Date

Nov 3, 2020Actual

First Submitted Date

Jul 31, 2015

First Submission Date that Met QC Criteria

Jul 31, 2015

First Posted Date

Aug 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2021

Last Update Posted Date

May 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

210 subjects Healthy (n=70), ill with non-GI disease (n=70), with GI disease (n=70) Age above 18 COnsent after full explanation Each subject completes 3 questionnaires Glasgow Dyspepsia Score Gastrointestinal Symptom Rating Scale New score This is a total of 48 questions Analysis will seek to validate the new score. There is no other intervention and no risks are anticipated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Form filling only	Gastrointestinal disorders Healthy Non-gastrointestinal disorders

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Construct validity measured by Validation of new score	Validation of new score	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unable to provide informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

As above

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Alastair Forbes, MD	UEA	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided