Is Recombinant Growth Hormone Therapy Associated With Inc... | NCT00867971

Studies
Is Recombinant Growth Hormone Therapy Associated With Increased Intraoccular Pressure?

NCT00867971

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Mar 24, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Growth Hormone Treatment
Glaucoma

Interventions

Measuring intraoccular pressure

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Oct 2010Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

Mar 22, 2009

First Submission Date that Met QC Criteria

Mar 22, 2009

First Posted Date

Mar 24, 2009Estimated

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

Mar 22, 2009

Last Update Posted Date

Mar 24, 2009Estimated

Description Module

Brief Summary

Recombinant growth hormone is a common therapy in the pediatric population. A number of associated side effects have been described. Several years ago, a case report was published concerning a child that was treated with RGH and developed acute glaucoma. To date no study has evaluated the connection.

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

Not provided

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RGH treated			Other: Measuring intraoccular pressure
Starting treatment with RGH			Other: Measuring intraoccular pressure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measuring intraoccular pressure	Other	Measurement of intraoccular pressure by tonometry	RGH treated Starting treatment with RGH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraoccular pressure in children treated with RGH		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 6-18 years
treatment with recombinant growth hormone

Exclusion Criteria:

Underlying Chronic diseases
Family history of eye diseases
elevated occular pressure prior to starting treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children age 6-18 treated with growth hormone

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf harofeh medical center		Ẕerifin			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22727870	Derived	Youngster I, Rachmiel R, Pinhas-Hamiel O, Bistritzer T, Zuckerman-Levin N, de Vries L, Naugolny L, Eyal O, Braunstein R, Rachmiel M. Treatment with recombinant human growth hormone during childhood is associated with increased intraocular pressure. J Pediatr. 2012 Dec;161(6):1116-9. doi: 10.1016/j.jpeds.2012.05.024. Epub 2012 Jun 23.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases