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

This study has been withdrawn prior to recruitment.

( No further local interest in pursuing the study. )

First Received: September 16, 2005 Last Updated: July 19, 2007 History of Changes

Sponsors and Collaborators:	Schering-Plough Fulford India Limited
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00202891

Purpose

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.

Condition	Intervention	Phase
Pyoderma	Drug: sisomicin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Sisomicin Sisomicin sulfate Opc 7251

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	210
Study Start Date:	May 2007
Estimated Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202891

Sponsors and Collaborators

Schering-Plough

Fulford India Limited

Investigators

Principal Investigator:

Ragunandan Torsekar, MD, FCPS

Rajiv Gandhi Medical College

More Information

No publications provided

Study ID Numbers:	P04460
Study First Received:	September 16, 2005
Last Updated:	July 19, 2007
ClinicalTrials.gov Identifier:	NCT00202891 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by Schering-Plough:

pyoderma
sisomicin
nadifloxacin

Study placed in the following topic categories:

Sisomicin
Anti-Infective Agents
Anti-Bacterial Agents
Skin Diseases
Pyoderma

Additional relevant MeSH terms:

Sisomicin
Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action

Skin Diseases
Therapeutic Uses
Pyoderma
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009