Mild Versus Potent Corticosteroids as Treatment for Phimo... | NCT00933023

Studies
Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

NCT00933023

Sponsor

Chelsea and Westminster NHS Foundation Trust

Status

Withdrawn

Last Update Posted

Jul 30, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Phimosis

Interventions

hydrocortisone
Betamethasone

Countries

United Kingdom

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 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Patient numbers estimated to be too low to complete the trial in less than 10 years

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Jul 6, 2009

First Submission Date that Met QC Criteria

Jul 6, 2009

First Posted Date

Jul 7, 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

Jul 28, 2015

Last Update Posted Date

Jul 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anindya Niyogi, Clinical Research Fellow, Chelsea and Westminster NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Chelsea and Westminster NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Topical steroids are used as treatment for non-retractile foreskin in children for decades, but, there are disagreement among physicians about the optimum potency of the agent used. This study is designed to determine any difference in the beneficial effects of mild versus potent topical corticosteroids in treatment of non-retractile foreskin in children.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mild steroid	Experimental	1%hydrocortisone for 8 weeks	Drug: hydrocortisone
Potent Steroid	Experimental		Drug: Betamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hydrocortisone	Drug	1%hydrocortisone topical once daily for 8 weeks	Mild steroid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Achievement of fully retractile foreskin with full exposure of glans at the end of therapy		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Complications of topical corticosteroids		16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children 2-16 with non-retractile foreskin

Exclusion Criteria:

Balanitis xerotica obliterans, balanitis, <2yrs

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anindya Niyogi, MBBS, MRCSEd	Research Fellow in Paediatric Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chelsea and Westminster Hospital		London			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D010688	Phimosis

Ancestor Terms

ID	Term
D010409	Penile Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006854	Hydrocortisone
D001623	Betamethasone

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided