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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00202891
Recruitment Status : Withdrawn (No further local interest in pursuing the study.)
First Posted : September 20, 2005
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Fulford India Limited
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pyoderma Drug: sisomicin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas
Study Start Date : May 2007
Actual Study Completion Date : September 2007
Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00202891    
Other Study ID Numbers: P04460
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Keywords provided by Merck Sharp & Dohme LLC:
pyoderma
sisomicin
nadifloxacin
Additional relevant MeSH terms:
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Pyoderma
Skin Diseases
Sisomicin
Anti-Bacterial Agents
 Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action