Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyoderma... | NCT00202891

Studies
Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas (Study P04460)

NCT00202891

Sponsor

Merck Sharp & Dohme LLC

Status

Withdrawn

Last Update Posted

Jun 3, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Pyoderma

Interventions

sisomicin

Countries

Not provided

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No further local interest in pursuing the study.

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Sep 16, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 20, 2005Estimated

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

Jun 2, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Name	Class
Fulford India Limited	UNKNOWN

Description Module

Brief Summary

This open-label, randomized, parallel-group clinical study is designed to compare the efficacy and safety of the topical antibiotic, sisomicin cream, with that of another topical antibiotic cream, nadifloxacin cream, in the treatment of Indian patients with primary pyodermas.

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

Name	Type	Description	Arm Group Labels	Other Names
sisomicin	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of either sex and suffering from primary pyodermas requiring topical antibiotic therapy without occlusive dressings.
>=6 years of age.
Written informed consent.

Exclusion Criteria:

Patients must not take any other antibiotics.
Patients should not be hypersensitive to any of the test drugs.
Patients are not to have any other investigational drug within one month of starting this study.
Patients cannot be enrolled more than once in the study.
Patients must not have any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment.
Pregnant women and nursing mothers are to be excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011711	Pyoderma

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012853	Sisomicin

Ancestor Terms

ID	Term
D005839	Gentamicins
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided