Prevalence of Chronic Abdominal Pain in Migraneurs | NCT05086562

Studies
Prevalence of Chronic Abdominal Pain in Migraneurs

NCT05086562

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Oct 28, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Migraine
IBD

Interventions

observation study

Countries

Germany

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Dec 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Sep 24, 2021

First Submission Date that Met QC Criteria

Oct 7, 2021

First Posted Date

Oct 21, 2021Actual

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

Oct 22, 2021

Last Update Posted Date

Oct 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Magdalena S. Prüß née Volz, Principal Investigator ; PD Dr. med., Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
observation study	Other	observation study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analog scale (VAS) for pain	Number of migraneurs with chronic abdominal pain based on the VAS	observational, through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic abdominal pain
migraine

Exclusion Criteria:

not able to sign written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Migraneurs with Chronic Abdominal Pain

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Magdalena S Prüß, MD	Contact	+493084452711		magdalena.pruess@charite.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University Medicine	Recruiting	Berlin		12200	Germany

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

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064887	Observational Studies as Topic

Ancestor Terms

ID	Term
D000068456	Clinical Studies as Topic
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided