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Trial: NCT00998309 [RDF]

Label NCT00998309
Slug nct00998309
Trialid NCT00998309
Lookup name NCT00998309
Provenance http://clinicaltrials.gov/show/NCT00998309?displayxml=true
Lastchanged date April 2, 2012
Firstreceived results date January 12, 2012
Firstreceived date October 16, 2009
Id info nct id NCT00998309
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 502
Number of arms
Is section 801 No
Is fda regulated Yes
Brief title Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
Acronym
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)
Study type Observational
Id info nct alias
Completion date January 2011
Verification date April 2012
Why stopped
Id info org study id A0661202
Required header url https://clinicaltrials.gov/show/NCT00998309
Study design Observational Model: Case-Only, Time Perspective: Prospective
Source Pfizer
Primary completion date January 2011
Brief summary
Number of groups 1
Required header download date ClinicalTrials.gov processed this data on September 07, 2016
Phase N/A
Start date October 2009
Has expanded access No
Biospec descr
Detailed description All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.
Condition browse f2c46e154ba156ed98fd32a7cef395cf
Intervention browse c65c4a2efde6abfabd5310db0a38c3a7
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group 332e579001b4df2b3ea4a2b655634651
Oversight info Japan: Pharmaceuticals and Medical Devices Agency (PMDA) (Oversight_info)
Eligibility 639521edd008bf223472abdf6ef34318
Keywords infection oral, Regulatory Post Marketing Commitment Plan, sexually-transmitted infection, skin infection, soft tissue infection
Conditions Bacterial Infections
Locations None
Links https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661202&StudyName=Zithromax-SR%202g%2C%20Special%20Investigation%20%28Regulatory%20Post%20Marketing%20Commitment%20Plan%29%20
Results references None
Arm groups Azithromycin SR (Arm Group)
Location countries None
Interventions Azithromycin SR (Intervention)
Secondary outcomes 024dcc5fb372bbd63f8e9ef095b4c8d8, 177cd1093f51ceca854627b52f1ee78f, 19da792227f73cca07cc4f524e91adf5 More →
References None
Primary outcomes 5629be38503a2ccaff823f24f0e347ff, 9df5f0c0830eee26be04e40f7f9fd58f, c721035c0aa9acfeda070a40dd977e39
Removed countries None
Overall officials e957c28872a0af6317858235cd1ddfaf