aCute HemORrhoidal Disease evALuation International Study | NCT04578730

Studies
aCute HemORrhoidal Disease evALuation International Study

NCT04578730

Sponsor

Servier Affaires Médicales

Status

Completed

Last Update Posted

Apr 13, 2023Actual

Enrollment

3,592Actual

Phase

Not provided

Conditions

Hemorrhoids

Interventions

Not provided

Countries

France

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 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2021Actual

Primary Completion Date

Nov 25, 2022Actual

Completion Date

Nov 25, 2022Actual

First Submitted Date

Sep 15, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 8, 2020Actual

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 12, 2023

Last Update Posted Date

Apr 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease

Detailed Description

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

3,592Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global improvement	Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.	Week 4
Signs and symptoms severity: pain, discomfort, bleeding, prolapse, swelling, itching, and soiling	Measured by VAS (Visual analogue scale) and questioning with 4 points rate	Week 4
Quality of Life	Measured by HEMO-FISS QoL	Week 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years old;
Patient consulting for symptomatic acute phase of hemorrhoidal disease
Confirmed diagnosis of hemorrhoidal disease

Exclusion Criteria:

Patient consulting for emergency not related to hemorrhoidal disease;
Patient currently taking any treatment for hemorrhoidal disease;
Any anorectal procedure or surgery planned during the study ;
Anorectal procedure or surgery performed or incomplete convalescence following anorectal procedure/surgery;
Known present perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury, diseases of the anal canal;
Pregnant or breastfeeding woman.

Accepts Healthy Volunteers

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

patients suffering from hemorrhoidal disease in the acute phase

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servier Affaires Medicales		Suresnes		92284	France

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided