PyodermaPhase 4NCT00202891
Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas (Study P04460)
A Phase 4 study testing sisomicin in people with Pyoderma, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Pyoderma
- What is being tested?
- sisomicin
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of either sex and suffering from primary pyodermas requiring topical antibiotic therapy without occlusive dressings.
- >=6 years of age.
- Written informed consent.
Who cannot join
- 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.
About this study
Official title: Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas
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.
- Conditions
- Pyoderma
- Being tested
- sisomicin
- Keywords
- pyoderma, sisomicin, nadifloxacin
- Medical subject headings
- Pyoderma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sisomicinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2007
- Study completionSep 2007
Why it stopped: No further local interest in pursuing the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyodermaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fulford India Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202891
- Sponsor's protocol ID
- P04460
- Status last verified
- Jun 2015
- First submitted
- 16 Sep 2005
- Last updated
- 3 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas
- ClinicalTrials.gov ID
- NCT00202891
- Acronym / sponsor ID
- P04460
- Conditions
- Pyoderma
- Keywords
- pyoderma, sisomicin, nadifloxacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No further local interest in pursuing the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Fulford India Limited
- Study start
- May 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of either sex and suffering from primary pyodermas requiring topical antibiotic therapy without occlusive dressings.
- >=6 years of age.
- Written informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sisomicin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sisomicin in people with Pyoderma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.