|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00174694 |
Purpose
Primary objective:
Secondary objective(s):
| Condition | Intervention | Phase |
|---|---|---|
|
Sinusitis |
Drug: Telithromycin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective, Randomized, Open-label, Active-controlled Study in Adult Subjects With Acute Bacterial Sinusitis Comparing the Clinical Efficacy of Telithromycin (KETEK®) 800 mg Once a Day for 5 Days Versus Amoxicillin-clavulanic Acid (AUGMENTIN®) 875/125 mg Twice a Day for 10 Days |
| Enrollment: | 298 |
| Study Start Date: | November 2004 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Outpatients with a clinical diagnosis of ABS, based on the presence of:
One additional major sign and symptom or 2 minor signs and symptoms. The major and minor signs and symptoms will be defined as the following:
Subjects with abnormal maxillary sinus x-rays (Waters views and additional views if necessary) or limited sinus CT scans or sinus ultrasound in the previous 48 hours before inclusion defined as the presence of at least 1 of the following homolateral radiological criteria:
Exclusion Criteria:
Related to the disease :
Related to the previous/concomitant medication :
Other exclusion criteria
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
| Study ID Numbers: | HMR3647A_4023, EudraCT # : 2004-001460-42 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00174694 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Anti-Infective Agents Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Paranasal Sinus Diseases Enzyme Inhibitors Sinusitis Amoxicillin-Potassium Clavulanate Combination |
Nose Diseases Telithromycin Pharmacologic Actions Anti-Bacterial Agents Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses |