Trial · NCT00402688
An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
NCT00402688, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2009-07-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis. Trials, record NCT00402688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00402688
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
- NCT number
- NCT00402688
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 242 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Prostatitis
- Interventions
- levofloxacin, levofloxacin, levofloxacin
- First posted
- 2006-11-22
- Last updated
- 2013-09-13
- Results first posted
- 2009-07-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Success | Posttherapy Visit (Study Day 33-36) | Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy. |
| Secondary | Symptom Relief (Resolved) | Posttherapy Visit (Study Day 33-36) | 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. |
| Secondary | Clinical Success (Non-Relapse) or Failure (Relapse) | Poststudy Telephone contact at 6 weeks | Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit |
| Secondary | Clinical Success (Non-Relapse) or Failure (Relapse) | Poststudy Telephone contact at 3 Months | Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit |
| Secondary | Clinical Success (Non-Relapse) or Failure (Relapse) | Poststudy Telephone Contact at 6 Months | Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit |
| Secondary | Total NIH-CPSI Score | Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36) | 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). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Success | Posttherapy Visit (Study Day 33-36) | Modified Intent to Treat (mITT) | Participants | NUMBER |
| SECONDARY | Symptom Relief (Resolved) | Posttherapy Visit (Study Day 33-36) | Modified Intent to Treat (mITT) | Participants | NUMBER |
| SECONDARY | Clinical Success (Non-Relapse) or Failure (Relapse) | Poststudy Telephone contact at 6 weeks | Modified Intent-to-Treat Population (mITT) (Participants Cured/Improved at the Posttherapy Visit) | participants | NUMBER |
| SECONDARY | Clinical Success (Non-Relapse) or Failure (Relapse) | Poststudy Telephone contact at 3 Months | Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit) | Participants | NUMBER |
| SECONDARY | Clinical Success (Non-Relapse) or Failure (Relapse) | Poststudy Telephone Contact at 6 Months | Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit) | Participants | NUMBER |
| SECONDARY | Total NIH-CPSI Score | Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36) | Modified Intent to Treat (mITT) | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group99
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Success | Levofloxacin 750mg for 2 Weeks | 46 | Participants | ||
| Clinical Success | Levofloxacin 750mg for 3 Weeks | 48 | Participants | ||
| Clinical Success | Levofloxacin 500mg for 4 Weeks | 52 | Participants | ||
| Symptom Relief (Resolved) | Levofloxacin 750mg for 2 Weeks | Dysuria (n=35, 43, 42) | 23 | Participants | |
| Symptom Relief (Resolved) | Levofloxacin 750mg for 3 Weeks | Dysuria (n=35, 43, 42) | 29 | Participants | |
| Symptom Relief (Resolved) | Levofloxacin 500mg for 4 Weeks | Dysuria (n=35, 43, 42) | 27 | Participants | |
| Symptom Relief (Resolved) | Levofloxacin 750mg for 2 Weeks | Suprapubic discomfort (n=41, 36, 45) | 24 | Participants | |
| Symptom Relief (Resolved) | Levofloxacin 750mg for 3 Weeks | Suprapubic discomfort (n=41, 36, 45) | 19 | Participants | |
| Symptom Relief (Resolved) | Levofloxacin 500mg for 4 Weeks | Suprapubic discomfort (n=41, 36, 45) | 30 | Participants | |
| Symptom Relief (Resolved) | Levofloxacin 750mg for 2 Weeks | Painful ejaculation (n=32, 39, 34) | 17 | Participants |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levofloxacin 750mg for 2 Weeks | 81 | |
| Overall Study | STARTED | Levofloxacin 750mg for 3 Weeks | 81 | |
| Overall Study | STARTED | Levofloxacin 500mg for 4 Weeks | 80 | |
| Overall Study | COMPLETED | Levofloxacin 750mg for 2 Weeks | 60 | |
| Overall Study | COMPLETED | Levofloxacin 750mg for 3 Weeks | 65 | |
| Overall Study | COMPLETED | Levofloxacin 500mg for 4 Weeks | 65 | |
| Overall Study | NOT COMPLETED | Levofloxacin 750mg for 2 Weeks | 21 | |
| Overall Study | NOT COMPLETED | Levofloxacin 750mg for 3 Weeks | 16 | |
| Overall Study | NOT COMPLETED | Levofloxacin 500mg for 4 Weeks | 15 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chest Pain | General disorders | Levofloxacin 750mg for 2 Weeks | 3 | 81 | |
| other | Chest Pain | General disorders | Levofloxacin 750mg for 3 Weeks | 0 | 81 | |
| other | Chest Pain | General disorders | Levofloxacin 500mg for 4 Weeks | 2 | 80 | |
| other | Fever | General disorders | Levofloxacin 750mg for 2 Weeks | 3 | 81 | |
| other | Fever | General disorders | Levofloxacin 750mg for 3 Weeks | 3 | 81 | |
| other | Fever | General disorders | Levofloxacin 500mg for 4 Weeks | 1 | 80 | |
| other | Back Pain | General disorders | Levofloxacin 750mg for 2 Weeks | 2 | 81 | |
| other | Back Pain | General disorders | Levofloxacin 750mg for 3 Weeks | 2 | 81 | |
| other | Back Pain | General disorders | Levofloxacin 500mg for 4 Weeks | 1 | 80 | |
| other | Pain | General disorders | Levofloxacin 750mg for 2 Weeks | 1 | 81 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levofloxacin 750mg for 2 Weeks | ||
| Total, all-cause mortality | Levofloxacin 750mg for 3 Weeks | ||
| Total, all-cause mortality | Levofloxacin 500mg for 4 Weeks | ||
| Total, other adverse events | Levofloxacin 750mg for 2 Weeks | 43 | |
| Total, other adverse events | Levofloxacin 750mg for 3 Weeks | 42 | |
| Total, other adverse events | Levofloxacin 500mg for 4 Weeks | 38 | |
| Total, serious adverse events | Levofloxacin 750mg for 2 Weeks | 2 | |
| Total, serious adverse events | Levofloxacin 750mg for 3 Weeks | 1 | |
| Total, serious adverse events | Levofloxacin 500mg for 4 Weeks | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20394471 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00402688
GET https://conductscience.org/api/trials/v1/NCT00402688/results?page=2