Trial Outcomes & Findings for An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis (NCT NCT00402688)
NCT ID: NCT00402688
Last Updated: 2013-09-13
Results Overview
Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
242 participants
Primary outcome timeframe
Posttherapy Visit (Study Day 33-36)
Results posted on
2013-09-13
Participant Flow
Participant milestones
| Measure |
Levofloxacin 750mg for 2 Weeks
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
80
|
|
Overall Study
COMPLETED
|
60
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
21
|
16
|
15
|
Reasons for withdrawal
| Measure |
Levofloxacin 750mg for 2 Weeks
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
9
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
4
|
5
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
|
Overall Study
Culture Show Fluoroquinolone Resistance
|
0
|
1
|
0
|
|
Overall Study
Urine Cult. Yield Resistant to Levaquin
|
0
|
0
|
1
|
|
Overall Study
Patient Left Town and Forgot Medication
|
0
|
0
|
1
|
Baseline Characteristics
An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
Baseline characteristics by cohort
| Measure |
Levofloxacin 750mg for 2 Weeks
n=81 Participants
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
n=81 Participants
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
n=80 Participants
levofloxacin, 500mg tablet once daily for 4 weeks.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Posttherapy Visit (Study Day 33-36)Population: Modified Intent to Treat (mITT)
Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.
Outcome measures
| Measure |
Levofloxacin 750mg for 2 Weeks
n=73 Participants
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
n=74 Participants
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
n=75 Participants
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
Clinical Success
|
46 Participants
|
48 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Posttherapy Visit (Study Day 33-36)Population: Modified Intent to Treat (mITT)
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.
Outcome measures
| Measure |
Levofloxacin 750mg for 2 Weeks
n=73 Participants
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
n=74 Participants
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
n=75 Participants
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
Symptom Relief (Resolved)
Dysuria (n=35, 43, 42)
|
23 Participants
|
29 Participants
|
27 Participants
|
|
Symptom Relief (Resolved)
Suprapubic discomfort (n=41, 36, 45)
|
24 Participants
|
19 Participants
|
30 Participants
|
|
Symptom Relief (Resolved)
Painful ejaculation (n=32, 39, 34)
|
17 Participants
|
23 Participants
|
20 Participants
|
|
Symptom Relief (Resolved)
Low back pain (n=43, 44, 44)
|
20 Participants
|
22 Participants
|
26 Participants
|
|
Symptom Relief (Resolved)
Perineal discomfort (n=40, 42, 50)
|
20 Participants
|
19 Participants
|
29 Participants
|
|
Symptom Relief (Resolved)
Frequency (n=58, 63, 62)
|
29 Participants
|
24 Participants
|
30 Participants
|
|
Symptom Relief (Resolved)
Urgency (n=48, 52, 58)
|
20 Participants
|
28 Participants
|
35 Participants
|
|
Symptom Relief (Resolved)
Hesitancy (n=37, 39, 54)
|
19 Participants
|
16 Participants
|
38 Participants
|
|
Symptom Relief (Resolved)
Decreased urinary stream (n=50, 47, 52)
|
24 Participants
|
21 Participants
|
30 Participants
|
|
Symptom Relief (Resolved)
Urinary retention (n=24, 26, 27)
|
13 Participants
|
13 Participants
|
17 Participants
|
|
Symptom Relief (Resolved)
Pain on digital rectal examination (n=60, 59, 61)
|
30 Participants
|
30 Participants
|
42 Participants
|
|
Symptom Relief (Resolved)
Perineal tenderness or pain (n=44, 38, 43)
|
28 Participants
|
24 Participants
|
28 Participants
|
|
Symptom Relief (Resolved)
Chills (n=4, 5, 7)
|
3 Participants
|
3 Participants
|
7 Participants
|
|
Symptom Relief (Resolved)
Other (n=5, 8, 8)
|
1 Participants
|
5 Participants
|
5 Participants
|
|
Symptom Relief (Resolved)
Fever (n=3, 2, 1)
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Poststudy Telephone contact at 6 weeksPopulation: Modified Intent-to-Treat Population (mITT) (Participants Cured/Improved at the Posttherapy Visit)
Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit
Outcome measures
| Measure |
Levofloxacin 750mg for 2 Weeks
n=46 Participants
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
n=48 Participants
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
n=52 Participants
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Clinical Success
|
38 participants
|
32 participants
|
44 participants
|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Failure
|
3 participants
|
12 participants
|
5 participants
|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Unable to Evaluate
|
0 participants
|
1 participants
|
1 participants
|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Missing
|
5 participants
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Poststudy Telephone contact at 3 MonthsPopulation: Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)
Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit
Outcome measures
| Measure |
Levofloxacin 750mg for 2 Weeks
n=46 Participants
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
n=48 Participants
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
n=52 Participants
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Clinical Success
|
30 Participants
|
24 Participants
|
38 Participants
|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Failure
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Unable to Evaluate
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Missing
|
8 Participants
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Poststudy Telephone Contact at 6 MonthsPopulation: Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)
Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit
Outcome measures
| Measure |
Levofloxacin 750mg for 2 Weeks
n=46 Participants
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
n=48 Participants
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
n=52 Participants
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Missing
|
16 Participants
|
24 Participants
|
14 Participants
|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Clinical Success
|
19 Participants
|
19 Participants
|
31 Participants
|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Failure
|
10 Participants
|
4 Participants
|
6 Participants
|
|
Clinical Success (Non-Relapse) or Failure (Relapse)
Unable to Evaluate
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)Population: Modified Intent to Treat (mITT)
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).
Outcome measures
| Measure |
Levofloxacin 750mg for 2 Weeks
n=73 Participants
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
n=74 Participants
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
n=75 Participants
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
Total NIH-CPSI Score
Screening/Admission (n=73, 74, 75)
|
11.8 Score on a scale
Interval 2.0 to 27.0
|
12.0 Score on a scale
Interval 3.0 to 27.0
|
12.9 Score on a scale
Interval 3.0 to 27.0
|
|
Total NIH-CPSI Score
On-Therapy (n=70, 70, 73)
|
7.2 Score on a scale
Interval 0.0 to 22.0
|
6.6 Score on a scale
Interval 0.0 to 19.0
|
6.9 Score on a scale
Interval 0.0 to 19.0
|
|
Total NIH-CPSI Score
Week 3 (Visit 2) (n=62, 65, 68)
|
6.5 Score on a scale
Interval 0.0 to 24.0
|
6.5 Score on a scale
Interval 0.0 to 21.0
|
5.6 Score on a scale
Interval 0.0 to 24.0
|
|
Total NIH-CPSI Score
Week 4 (Visit 3) (n=53, 57, 61)
|
5.1 Score on a scale
Interval 0.0 to 19.0
|
4.9 Score on a scale
Interval 0.0 to 17.0
|
4.5 Score on a scale
Interval 0.0 to 25.0
|
|
Total NIH-CPSI Score
Posttherapy (Visit 4) (n=70, 71, 71)
|
5.4 Score on a scale
Interval 0.0 to 24.0
|
5.0 Score on a scale
Interval 0.0 to 21.0
|
4.6 Score on a scale
Interval 0.0 to 22.0
|
Adverse Events
Levofloxacin 750mg for 2 Weeks
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Levofloxacin 750mg for 3 Weeks
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Levofloxacin 500mg for 4 Weeks
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levofloxacin 750mg for 2 Weeks
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
General disorders
Syncope
|
1.2%
1/81
|
0.00%
0/81
|
0.00%
0/80
|
|
Vascular disorders
Coronary Artery Disorder
|
1.2%
1/81
|
0.00%
0/81
|
0.00%
0/80
|
|
Psychiatric disorders
Depression
|
0.00%
0/81
|
1.2%
1/81
|
0.00%
0/80
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/81
|
1.2%
1/81
|
0.00%
0/80
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/81
|
1.2%
1/81
|
0.00%
0/80
|
Other adverse events
| Measure |
Levofloxacin 750mg for 2 Weeks
levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
|
Levofloxacin 750mg for 3 Weeks
levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
|
Levofloxacin 500mg for 4 Weeks
levofloxacin, 500mg tablet once daily for 4 weeks.
|
|---|---|---|---|
|
General disorders
Chest Pain
|
3.7%
3/81
|
0.00%
0/81
|
2.5%
2/80
|
|
General disorders
Fever
|
3.7%
3/81
|
3.7%
3/81
|
1.2%
1/80
|
|
General disorders
Back Pain
|
2.5%
2/81
|
2.5%
2/81
|
1.2%
1/80
|
|
General disorders
Pain
|
1.2%
1/81
|
6.2%
5/81
|
2.5%
2/80
|
|
General disorders
Fatigue
|
0.00%
0/81
|
1.2%
1/81
|
2.5%
2/80
|
|
General disorders
Oedema Peripheral
|
0.00%
0/81
|
1.2%
1/81
|
2.5%
2/80
|
|
Cardiac disorders
Hypertension
|
0.00%
0/81
|
2.5%
2/81
|
1.2%
1/80
|
|
Nervous system disorders
Dizziness
|
11.1%
9/81
|
3.7%
3/81
|
2.5%
2/80
|
|
Nervous system disorders
Headache
|
3.7%
3/81
|
4.9%
4/81
|
3.8%
3/80
|
|
Gastrointestinal disorders
Nausea
|
9.9%
8/81
|
7.4%
6/81
|
2.5%
2/80
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
5/81
|
6.2%
5/81
|
6.2%
5/80
|
|
Gastrointestinal disorders
Constipation
|
4.9%
4/81
|
1.2%
1/81
|
2.5%
2/80
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.7%
3/81
|
1.2%
1/81
|
7.5%
6/80
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
3/81
|
1.2%
1/81
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
4/81
|
2.5%
2/81
|
2.5%
2/81
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
3/81
|
3.7%
3/81
|
0.00%
0/80
|
|
Musculoskeletal and connective tissue disorders
Skeletal Pain
|
3.7%
3/81
|
1.2%
1/81
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Fascitis Plantar
|
2.5%
2/81
|
0.00%
0/81
|
0.00%
0/80
|
|
Psychiatric disorders
Insomnia
|
6.2%
5/81
|
2.5%
2/81
|
3.8%
3/80
|
|
Reproductive system and breast disorders
Penis Disorder
|
0.00%
0/81
|
2.5%
2/81
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/81
|
1.2%
1/81
|
2.5%
2/80
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/81
|
0.00%
0/81
|
2.5%
2/80
|
|
Skin and subcutaneous tissue disorders
Sweating Increased
|
0.00%
0/81
|
2.5%
2/81
|
2.5%
2/80
|
Additional Information
Therapeutic Area Lead, Anti-Infective Franchise
Ortho-McNeil Janssen Scientific Affairs, LLC
Phone: 908-927-5220
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60