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

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Primary Purpose

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

sisomicin

About this trial

This is an interventional treatment trial for Pyoderma focused on measuring pyoderma, sisomicin, nadifloxacin

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00202891

First Posted

September 16, 2005

Last Updated

June 2, 2015

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Fulford India Limited

1. Study Identification

Unique Protocol Identification Number

NCT00202891

Brief Title

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

Official Title

Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Withdrawn

Why Stopped

No further local interest in pursuing the study.

Study Start Date

May 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

Collaborators

Fulford India Limited

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pyoderma

Keywords

pyoderma, sisomicin, nadifloxacin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

sisomicin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

No

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.

Pyoderma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial