Last updated: 11/07/2018 13:28:50
A randomised, double-blind, double-dummy, multicentre, parallel group study to assess the efficacy and safety of oral Augmentin SR 2000/125mg twice daily for 5 days versus oral Augmentin 875/125mg twice daily for 7 days in the treatment of adults with acute exacerbations of chronic bronchitis.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, double-blind, double-dummy, multicentre, parallel group study to assess the efficacy and safety of oral Augmentin SR 2000/125mg twice daily for 5 days versus oral Augmentin 875/125mg twice daily for 7 days in the treatment of adults with acute exacerbations of chronic bronchitis.
Trial description: A randomised, double-blind, double-dummy, multicentre, parallel group study to assess the efficacy and safety of oral Augmentin SR 2000/125mg twice daily for 5 days versus oral Augmentin 875/125mg twice daily for 7 days in the treatment of adults with acute exacerbations of chronic bronchitis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
S. Miller, M. Twynholm, E. Berkowitz, S. Gormley, A. White, L.A. Miller, C. Jakielaszek. Bacteriological outcomes with pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in patients with community-acquired respiratory infection caused by Streptococcus pneumoniae, including drug-resistant (DRSP) strains. Abstracts from the 15th European Congress of Clinical Microbiology and Infectious Diseases, April 2005.
Sethi S, Breton J, Wynne B. Efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanate (AMX/CA) 2000/125 mg bid for 5 days vs AMX/CA 875/125 mg bid for 7 days in the treatment of acute exacerbations of chronic bronchitis (AECB). Abstracts from the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, USA. September 2003, page 427, Abstract L-1592.
Sethi S, Breton J, Wynne B. Efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanate (AMX/CA) 2000/125 mg bid for 5 days vs AMX/CA 875/125 mg bid for 7 days in the treatment of acute exacerbations of chronic bronchitis (AECB). Antimicrob Agents Chemother 2005; 49(1): 153–60.
Medical condition
Bronchitis, Chronic
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
November 2001 to May 2002
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-24-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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