Incidence of Various Types of Systemic Reactions Related... | NCT01756196

Status Module

Record Verification Date

Dec 2012

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

Oct 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 19, 2012

First Submission Date that Met QC Criteria

Dec 19, 2012

First Posted Date

Dec 25, 2012Estimated

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

Dec 19, 2012

Last Update Posted Date

Dec 25, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guen Young Lee, Associate Professor, MD, PhD, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

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

Many systemic reactions occur commonly after spinal steroid injections, especially in patients, and may be associated with underlying disease, such as hypertension and diabetes mellitus, as well as steroid dose and repetition of spinal steroid injection.

Detailed Description

Evaluate the incidence and types of systemic reactions after spinal steroid injections and to investigate the association of spinal steroid injection with patient demographics, history of previous injections, type and dose of steroid, and method and site of previous and current injections.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

997Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Steroid Injection		Reactions associated with spinal steroid injection	Drug: Spinal Steroid Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinal Steroid Injection	Drug	Steroid Injection	Steroid Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
episodes of systemic reactions after spinal steroid injection	Evaluation of episodes of systemic reactions after spinal steroid injection	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indicaion of steroid injction.

Exclusion Criteria:

Contraindiation of steroid injction.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

94 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients receiving the injection were informed of the aim and protocol of this study and the possible local and systemic reactions associated with spinal steroid injection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seoung Nam	Bundang	463-802	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
49801	Result	Goldstein G, Schlesinger DH. Thymopoietin and myasthenia gravis: neostigmine-responsive neuromuscular block produced in mice by a synthetic peptide fragment of thymopoietin. Lancet. 1975 Aug 9;2(7928):256-9. doi: 10.1016/s0140-6736(75)90966-6.

Type	Date	Date Unknown
Release	Jan 8, 2013
Reset	Feb 8, 2013
Release	Jul 1, 2013

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 8, 2013			Feb 8, 2013
Jul 1, 2013			Aug 2, 2013

ID	Term
D003920	Diabetes Mellitus
D006973	Hypertension

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases