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

Pyoderma Clinical Trial

Official title:

Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00202891
• Other study ID #: P04460
• Status: Withdrawn
• Phase: Phase 4
• First received: September 16, 2005
• Last updated: June 2, 2015
• Start date: May 2007
• Est. completion date: September 2007

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pyoderma

Intervention

Drug:
• sisomicin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Fulford India Limited