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

NCT ID: NCT00202891

Last Updated: 2015-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-09-30

Brief Summary

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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

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Conditions

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Pyoderma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sisomicin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fulford India Limited

UNKNOWN

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P04460

Identifier Type: -

Identifier Source: org_study_id

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