BAY12-8039: 5 Days for Sinusitis vs Placebo
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00492024
First received: June 26, 2007
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Sinusitis |
Drug: Moxifloxacin (Avelox, BAY12-8039) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg QD for 5 Days Versus Placebo in the Treatment of Acute Bacterial Sinusitis |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT)) [ Time Frame: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment ] [ Designated as safety issue: No ]The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.
Secondary Outcome Measures:
- Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach [ Time Frame: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) ] [ Designated as safety issue: No ]The Sino-Nasal Outcome Test (SNOT-16) was used to assess subject-reported time to symptom improvement. Improvement was defined as a decrease of at least 14 units on the test. This difference is the smallest difference that has been identified as beneficial to subjects.
- Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach [ Time Frame: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) ] [ Designated as safety issue: No ]The Activity Impairment Assessment (AIA) questionnaire was used to assess activity impairment at baseline and time to return to normal activities. The AIA was administered prior to first dose, every 24 hours during treatment, and at the TOC visit. Improvement in the AIA total score was defined as a decrease of at least 3 units.
- Percentage of Subjects With Clinical Improvement During Therapy [ Time Frame: Day 3 of treatment ] [ Designated as safety issue: No ]A secondary efficacy variable was clinical response (CR) at the During Therapy visit at day 3 or 4 of treatment. CR was rated as improvement, cure, failure, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.
- Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up [ Time Frame: Day 12 to 26 after end of treatment ] [ Designated as safety issue: No ]A secondary efficacy variable was clinical response (CR) at the Follow-up visit 17-21 days following the start of treatment. CR was rated as continued cure, failure/relapse, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.
Other Outcome Measures:
- Percentage of Subjects With Clinical Cure (Per Protocol Population (PP)) [ Time Frame: At 'Test-of-Cure', Day 1-5 after end of treatment ] [ Designated as safety issue: No ]The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.
| Enrollment: | 374 |
| Study Start Date: | January 2005 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Moxifloxacin 400 mg
Moxifloxacin 400mg once daily for 5 days
|
Drug: Moxifloxacin (Avelox, BAY12-8039)
Moxifloxacin - 400 mg once a day for 5 days
|
|
Placebo Comparator: Placebo
Matching placebo for 5 days
|
Drug: Placebo
Placebo - 380 mg Microcrystalline Cellulose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Subjects must meet all the following criteria at the time of enrollment:
- Age >/= 18 years
Clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:
- Radiographic Criteria: The presence of one or more of the following on a radiographic paranasal sinus film (Waters' view): - Evidence of air-fluid levels - Opacification
Clinical Criteria: The presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below:
- Major symptoms: - Purulent anterior or posterior nasal discharge - Unilateral facial pain or malar tenderness
- Minor symptoms: - Frontal headache - Fever (oral = 38.0°C/100.4°F, tympanic = 38.5°C/101.2°F, axillary = 37.5°C/99.5°F) - Culture material obtained by sinus puncture; the aspirated specimen sent for Gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy
Exclusion Criteria:
Subjects with one or more of the following criteria will not be eligible for this study:
- History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included)
- History of sinus surgery (antral sinus puncture is not considered as a surgery)
- Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
- Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492024
Show 51 Study Locations
Show 51 Study LocationsSponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
Publications:
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00492024 History of Changes |
| Other Study ID Numbers: | 11566 |
| Study First Received: | June 26, 2007 |
| Results First Received: | March 19, 2009 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Respiratory Tract Infection Bacterial Sinusitis |
Additional relevant MeSH terms:
|
Sinusitis Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013