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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00998309

Purpose

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

Condition	Intervention	Phase
Bacterial Infections	Drug: Azithromycin SR	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
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)

Resource links provided by NLM:

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The frequency of treatment related adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Unlisted treatment related adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The proportion of responders to azithromycin-SR treatment. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Risk factors likely to affect the proportion of responders. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment:	502
Study Start Date:	October 2009
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Azithromycin SR Patients taking Azithromycin.	Drug: Azithromycin SR Zithromax SR 2g, taking once for treatment. Other Name: Zithromax SR, Azithromycin SR

Detailed Description:

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

Eligibility

Study Population

The patients whom an involving A0661202 prescribes the Azithromycin SR.

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998309

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00998309 History of Changes
Other Study ID Numbers:	A0661202
Study First Received:	October 16, 2009
Last Updated:	February 24, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Pfizer:

skin infection
soft tissue infection
sexually-transmitted infection
infection oral
Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:

Bacterial Infections
Sexually Transmitted Diseases
Soft Tissue Infections
Infection
Virus Diseases
Genital Diseases, Male

Genital Diseases, Female
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012