Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)

Verified by: Pfizer, February 2011
First Received: October 16, 2009 | Last Updated: February 24, 2011 | Phase: Phase 4 | Start Date: October 2009
Overall Status: Completed | Estimated Enrollment: 502
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To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice...

Brief Summary

Official Title: “Zithromax-SR 2g, Special Investigation For Skin And Soft Tissue Infection, Sexually-Transmitted Infection, And Infection Of The Oral (Regulatory Post Marketing Commitment Plan)”

To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.

  • Study Type: Observational
  • Study Design: Observational Model: Case-Only, Time Perspective: Prospective
  • Study Primary Completion Date: January 2011

Detailed Clinical Trial Description

All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.

Intervention(s) in this Clinical Trial

  • Drug: Azithromycin SR
    • Zithromax SR 2g, taking once for treatment.

Arms, Groups and Cohorts in this Clinical Trial

  • : Azithromycin SR
    • Patients taking Azithromycin.

Outcome Measures for this Clinical Trial

Primary Measures

  • The frequency of treatment related adverse events.
    • Time Frame: 28 days
      Safety Issue?: Yes
  • Risk factors likely to affect the frequency of treatment related adverse events.
    • Time Frame: 28 days
      Safety Issue?: Yes
  • Unlisted treatment related adverse events.
    • Time Frame: 28 days
      Safety Issue?: Yes

Secondary Measures

  • The proportion of responders to azithromycin-SR treatment.
    • Time Frame: 28 days
      Safety Issue?: Yes
  • Risk factors likely to affect the proportion of responders.
    • Time Frame: 28 days
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male or female subjects diagnosed with skin and soft tissue infection, sexually-transmitted infection, and infection of the oral.
  • Subjects must have no prior experience with Azithromycin SR.

Exclusion Criteria:

  • Patients not administered Azithromycin SR.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00998309

Study ID Number: A0661202

ClinicalTrials.gov Identifier: NCT00998309

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

To obtain contact information for a study center near you, click here.

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