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| ID | Type | Description | Link |
|---|---|---|---|
| CR012103 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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| Name | Class |
|---|---|
| PriCara, Unit of Ortho-McNeil, Inc. | INDUSTRY |
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The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis.
The optimal duration of treatment for chronic prostatitis remains unclear. Historically, therapy for chronic prostatitis with other classes of antibacterials resulted in poor outcomes and prolonged time taking the medication. Levofloxacin belongs to the quinolone class of antibacterials and has been used to treat chronic prostatitis with 500mg of levofloxacin taken orally once a day for 4 weeks. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance) study is designed to see if giving levofloxacin at a higher dose for shorter periods of time is safe and effective in treating chronic prostatitis. Safety analyses will involve the examination of the incidence, severity, and type of adverse events and changes in physical findings including vital signs and clinical laboratory tests. Patients will receive one of the following three dosing options: levofloxacin 750 mg orally administered once-a-day for 2 weeks followed by placebo once-a-day for two weeks for a total of 4 weeks, or levofloxacin 750 mg orally once-a-day for 3 weeks followed by placebo once-a-day for one week for a total of 4 weeks, or levofloxacin 500 mg orally once-a-day for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Active Comparator | levofloxacin 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo. |
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| 002 | Active Comparator | levofloxacin 750mg tablet once daily for 3 weeks followed by 1 week of placebo. |
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| 003 | Active Comparator | levofloxacin 500mg tablet once daily for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levofloxacin | Drug | 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy. | Posttherapy Visit (Study Day 33-36) |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Relief (Resolved) | Participants With Resolution of Prostatitis Signs and Symptoms; Resolution is defined as symptoms present (mild, moderate or severe) at Screening/Admission and absent (none) at the Posttherapy evaluation. | Posttherapy Visit (Study Day 33-36) |
| Clinical Success (Non-Relapse) or Failure (Relapse) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20394471 | Derived | Paglia M, Peterson J, Fisher AC, Qin Z, Nicholson SC, Kahn JB. Safety and efficacy of levofloxacin 750 mg for 2 weeks or 3 weeks compared with levofloxacin 500 mg for 4 weeks in treating chronic bacterial prostatitis. Curr Med Res Opin. 2010 Jun;26(6):1433-41. doi: 10.1185/03007991003795030. |
| Label | URL |
|---|---|
| An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levofloxacin 750mg for 2 Weeks | levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo. |
| FG001 | Levofloxacin 750mg for 3 Weeks | levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| levofloxacin |
| Drug |
750mg tablet once daily for 3 weeks followed by 1 week of placebo. |
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| levofloxacin | Drug | 500mg tablet once daily for 4 weeks. |
|
Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit |
| Poststudy Telephone contact at 6 weeks |
| Clinical Success (Non-Relapse) or Failure (Relapse) | Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit | Poststudy Telephone contact at 3 Months |
| Clinical Success (Non-Relapse) or Failure (Relapse) | Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit | Poststudy Telephone Contact at 6 Months |
| Total NIH-CPSI Score | National Institute of Health-Chronic Prostatitis Symptom Index numerically rates a total score (0-43) where 0 indicates no symptoms across any of the domains (pain or discomfort, urination, quality of life). | Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36) |
| Homewood |
| Alabama |
| United States |
| Anchorage | Alaska | United States |
| Hot Springs | Arkansas | United States |
| Fresno | California | United States |
| San Diego | California | United States |
| Denver | Colorado | United States |
| New Britain | Connecticut | United States |
| New Smyrna Beach | Florida | United States |
| Ocala | Florida | United States |
| Orlando | Florida | United States |
| Ormond Beach | Florida | United States |
| Plantation | Florida | United States |
| St. Petersburg | Florida | United States |
| Tallahassee | Florida | United States |
| Tampa | Florida | United States |
| Wellington | Florida | United States |
| Columbus | Georgia | United States |
| Roswell | Georgia | United States |
| Jeffersonville | Indiana | United States |
| Des Moines | Iowa | United States |
| Shreveport | Louisiana | United States |
| Greenbelt | Maryland | United States |
| St Louis | Missouri | United States |
| Las Vegas | Nevada | United States |
| Marlton | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Garden City | New York | United States |
| Kingston | New York | United States |
| New York | New York | United States |
| Orchard Park | New York | United States |
| Poughkeepsie | New York | United States |
| Staten Island | New York | United States |
| Salisbury | North Carolina | United States |
| Columbus | Ohio | United States |
| Bethany | Oklahoma | United States |
| Allentown | Pennsylvania | United States |
| Bala-Cynwyd | Pennsylvania | United States |
| State College | Pennsylvania | United States |
| FG002 | Levofloxacin 500mg for 4 Weeks | levofloxacin, 500mg tablet once daily for 4 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Levofloxacin 750mg for 2 Weeks | levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo. |
| BG001 | Levofloxacin 750mg for 3 Weeks | levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo. |
| BG002 | Levofloxacin 500mg for 4 Weeks | levofloxacin, 500mg tablet once daily for 4 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Clinical Success | Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy. | Modified Intent to Treat (mITT) | Posted | Number | Participants | Posttherapy Visit (Study Day 33-36) |
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| Secondary | Symptom Relief (Resolved) | Participants With Resolution of Prostatitis Signs and Symptoms; Resolution is defined as symptoms present (mild, moderate or severe) at Screening/Admission and absent (none) at the Posttherapy evaluation. | Modified Intent to Treat (mITT) | Posted | Number | Participants | Posttherapy Visit (Study Day 33-36) |
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| Secondary | Clinical Success (Non-Relapse) or Failure (Relapse) | Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit | Modified Intent-to-Treat Population (mITT) (Participants Cured/Improved at the Posttherapy Visit) | Posted | Number | participants | Poststudy Telephone contact at 6 weeks |
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| Secondary | Clinical Success (Non-Relapse) or Failure (Relapse) | Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit | Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit) | Posted | Number | Participants | Poststudy Telephone contact at 3 Months |
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| Secondary | Clinical Success (Non-Relapse) or Failure (Relapse) | Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit | Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit) | Posted | Number | Participants | Poststudy Telephone Contact at 6 Months |
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| Secondary | Total NIH-CPSI Score | National Institute of Health-Chronic Prostatitis Symptom Index numerically rates a total score (0-43) where 0 indicates no symptoms across any of the domains (pain or discomfort, urination, quality of life). | Modified Intent to Treat (mITT) | Posted | Mean | Full Range | Score on a scale | Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levofloxacin 750mg for 2 Weeks | levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo. | 2 | 43 | ||||
| EG001 | Levofloxacin 750mg for 3 Weeks | levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo. | 1 | 42 | ||||
| EG002 | Levofloxacin 500mg for 4 Weeks | levofloxacin, 500mg tablet once daily for 4 weeks. | 0 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | General disorders | WHOART 1997 | Systematic Assessment |
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| Coronary Artery Disorder | Vascular disorders | WHOART 1997 | Systematic Assessment |
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| Depression | Psychiatric disorders | WHOART 1997 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | WHOART 1997 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | WHOART 1997 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | WHOART 1997 | Systematic Assessment |
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| Fever | General disorders | WHOART 1997 | Systematic Assessment |
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| Back Pain | General disorders | WHOART 1997 | Systematic Assessment |
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| Pain | General disorders | WHOART 1997 | Systematic Assessment |
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| Fatigue | General disorders | WHOART 1997 | Systematic Assessment |
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| Oedema Peripheral | General disorders | WHOART 1997 | Systematic Assessment |
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| Hypertension | Cardiac disorders | WHOART 1997 | Systematic Assessment |
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| Dizziness | Nervous system disorders | WHOART 1997 | Systematic Assessment |
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| Headache | Nervous system disorders | WHOART 1997 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | WHOART 1997 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | WHOART 1997 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | WHOART 1997 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | WHOART 1997 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | WHOART 1997 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | WHOART 1997 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | WHOART 1997 | Systematic Assessment |
| |
| Skeletal Pain | Musculoskeletal and connective tissue disorders | WHOART 1997 | Systematic Assessment |
| |
| Fascitis Plantar | Musculoskeletal and connective tissue disorders | WHOART 1997 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | WHOART 1997 | Systematic Assessment |
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| Penis Disorder | Reproductive system and breast disorders | WHOART 1997 | Systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | WHOART 1997 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | WHOART 1997 | Systematic Assessment |
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| Sweating Increased | Skin and subcutaneous tissue disorders | WHOART 1997 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Lead, Anti-Infective Franchise | Ortho-McNeil Janssen Scientific Affairs, LLC | 908-927-5220 |
| ID | Term |
|---|---|
| D011472 | Prostatitis |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Risk Difference (RD) |
| 0.045 |
| 95 |
| -0.106 |
| 0.195 |
Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 3 weeks). |
| Yes |
| Non-Inferiority or Equivalence |
Non-inferiority margin is a risk difference of 0.2. |
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