The Percentage of Cases of Acute Treatment With Allopurin... | NCT03601260

Studies
The Percentage of Cases of Acute Treatment With Allopurinol in Gout Patients

NCT03601260

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jul 26, 2018Actual

Enrollment

700Estimated

Phase

Not Applicable

Conditions

Gout

Interventions

Allopurinol

Countries

Israel

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2018Estimated

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 18, 2018

First Submission Date that Met QC Criteria

Jul 18, 2018

First Posted Date

Jul 26, 2018Actual

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

Jul 18, 2018

Last Update Posted Date

Jul 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of the study is to determine the percentage of cases of acute treatment with Allopurinol in gout patients who have been previously treated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gout Patients	Other	Allopurinol 100 mg-300mg/day as secondary treatment in gout patients	Drug: Allopurinol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Allopurinol	Drug	Treatment of gout patients by oral dosage of 100 mg-300mg/ day of Allopurinol	Gout Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gout patients treated with Allopurinol	Retrospective identification through medical records of percentage of gout patients treated with Allopurinol	Six months

Secondary Outcomes

Measure	Description	Time Frame
Patients with contraindication to Allopurinol	Retrospective identification through medical records of percentage of gout patients with contraindications to Allopurinol	Six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gout patients

Exclusion Criteria:

Pregnant women
Chronic renal failure
Patients with Allopurinal hypersensitivity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fadi Khalaila, MD	Contact	972-52-3326629		khalailaf@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006073	Gout

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070657	Crystal Arthropathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000493	Allopurinol

Ancestor Terms

ID	Term
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided