Who is sponsoring NCT01189487?

NCT01189487 is sponsored by Pfizer.

What condition does NCT01189487 study?

NCT01189487 studies Pneumonia, Bacterial.

What drugs are being tested in NCT01189487?

Interventions: ampicillin sodium/sulbactam sodium.

What is the status of NCT01189487?

NCT01189487 is currently COMPLETED.

Last reviewed 2012-07-09 · How we verify

A Multicenter, Unblinded, Non-Comparative Study Of Unasyn-S 12 G/Day Evaluating The Safety And Efficacy In Japanese Adult Subjects With Community Acquired Pneumonia

NCT01189487 Phase 3 COMPLETED Results posted

Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.

Details

Lead sponsor	Pfizer
Phase	Phase 3
Status	COMPLETED
Enrolment	47
Start date	2010-10
Completion	2011-04

Conditions

Pneumonia, Bacterial

Interventions

ampicillin sodium/sulbactam sodium

Primary outcomes

Response Rate (Clinical Response, Data Review Committee Assessment) — End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.

Countries

Japan