Indomethacin SR |
Indocin SR |
Clinical Trial: A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis
This study is not yet open for patient recruitment.
Verified by Pfizer December 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Bronchitis, Chronic | Drug: Azithromycin SR Drug: Moxifloxacin | Phase III |
MedlinePlus related topics: Bronchitis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3B Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial To Evaluate The Efficacy and Safety Of Azithromycin SR (Microspheres Formulation) Versus Moxifloxacin For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB).
Secondary Outcomes: Bacteriologic response at Test of cure visit Time to first recurrence of AECB Health status Safety and tolerability
Expected Total Enrollment: 416
Study start: January 2006
Eligibility
Inclusion Criteria:
- Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms:
- Production of purulent sputum as defined by Gram stained sputum specimen
- Presence of all of the following:
i. Increased sputum production
ii. Increased dyspnea
iii. Increased cough
- At least two exacerbations of AECB in the past 12 months
Exclusion Criteria:
- A chest radiograph consistent with pneumonia
- Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation
Location and Contact Information
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Last Updated: January 3, 2006
Record first received: November 14, 2005
ClinicalTrials.gov Identifier: NCT00254566
Health Authority: Singapore: Health Sciences Authority
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Indocin SR (Drug Digest)
- Indomethacin SR (Drug Digest)

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