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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK065209 | U.S. NIH Grant/Contract | View source |
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The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Primary Objectives
Design
Eligible participants will receive either pregabalin or placebo, randomly assigned at a ratio of 2:1. Study treatment will be for 6 weeks with dose starting at 150mg going up to 300mg and finally to 600mg daily, to maximum tolerated dose. Participants will be advised to take the study medication 3 times per day. There are 3 clinic visits and 2 telephone contacts. Participants will be offered optional active treatment for an additional 6 weeks at the end of the first 6 weeks. For those participating in both phases there are a total of 4 clinic visits and 5 telephone contacts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in the NIH-CPSI Total Score by at Least 6 Points | Decrease (improvement) in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. The NIH-CPSI measures the 3 key domains of CP/CPPS: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subscales of the NIH-CPSI | The National Institutes of Health -Chronic Prostatitis Symptom Index (NIH-CPSI) measures the 3 key domains of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A higher score indicates more severe symptoms. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Kusek, PhD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Study Director |
| Lee Nyberg, PhD, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles R Drew University of Medicine & Science | Los Angeles | California | 90059 | United States | ||
| David Geffen School of Medicine at UCLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20876412 | Derived | Pontari MA, Krieger JN, Litwin MS, White PC, Anderson RU, McNaughton-Collins M, Nickel JC, Shoskes DA, Alexander RB, O'Leary M, Zeitlin S, Chuai S, Landis JR, Cen L, Propert KJ, Kusek JW, Nyberg LM Jr, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network-2. Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial. Arch Intern Med. 2010 Sep 27;170(17):1586-93. doi: 10.1001/archinternmed.2010.319. |
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Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/cpcrn2-rct2/?query=cpcrn2
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-Pregabalin | Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Placebo at same frequency as pregabablin |
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| 6 weeks |
| Moderately or Markedly Improve on Global Response Assessment (GRA) | The GRA is a 7-question patient self-reported assessment that measures perception of change in symptoms (improvement, no change, or deterioration). The responses are centered at zero (no change in symptoms). Men who reported that they were moderately or markedly improved on a 7-point GRA at the end of the study were identified as treatment responders. | 6 weeks |
| Hospital Anxiety & Depression Scale | Hospital Anxiety and Depression Scale (HADS) (range, 0-42, with higher scores indicating greater anxiety and depression) | 6 weeks |
| McGill Pain Questionnaire | The McGill Pain Questionnaire (MPQ) evaluates the quality of pain as well as the intensity of pain. The McGill Pain Questionnaire ranges from 0-45 for a total pain score, and is the sum of a sensory subscore of 0-33 and affective subscore of 0-12. Higher scores indicate greater pain. | 6 weeks |
| Medical Outcomes Study Short Form 12 | Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) (range, 0-100 for the Physical [PCS] and Mental [MCS] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life) | 6 weeks |
| Sexual Health Inventory for Men | Sexual Health Inventory for Men (SHIM) (range, 1-25, with higher scores indicating better sexual function) | 6 weeks |
| Los Angeles |
| California |
| 90095-1738 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305-5118 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Harvard Medical School | Boston | Massachusetts | 02115 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | United States |
| University of Washington Harborview Medical Center | Seattle | Washington | 98108 | United States |
| Queen's University | Kingston | Ontario | K7L 2V7 | Canada |
| FG001 | 2-Placebo | Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed. |
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| NOT COMPLETED |
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Based on evaluable participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-Pregabalin | Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed. |
| BG001 | 2-Placebo | Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed. |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| NIH-CPSI total score (possible score, 0-43) | The National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) measures the 3 key domains of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A higher score indicates more severe symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| NIH-CPSI pain subscore (possible score, 0-21) | The National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) pain subscore is determined by location, frequency, and severity of pain symptoms with a possible score of 0-21. A higher score indicates more severe symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| NIH-CPSI urinary symptoms subscore (possible score, 0-10) | The National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary subscore measures irritative and obstructive symptoms with a possible score of 0-10. A higher score indicates more severe symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| NIH-CPSI QOL subscore (possible score, 0-12) | The National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) impact/quality of life subscore measures participant-reported symptoms with a possible score, 0-12. A higher score indicates more severe symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| SF-12 PCS score (possible score, 0-100) | The Medical Outcomes Study 12-item Short Form Survey (SF-12) is a general health questionnaire that is comprised of a mental component score (MCS-12) and a physical component score (PCS-12). The SF-12 ranges from 0-100 for the Physical [PCS] and Mental [MCS] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life. | Based on evaluable patient data | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| SF-12 MCS score (possible score, 0-100) | The Medical Outcomes Study 12-item Short Form Survey (SF-12) is a general health questionnaire that is comprised of a mental component score (MCS-12) and a physical component score (PCS-12). The SF-12 ranges from 0-100 for the Physical [PCS] and Mental [MCS] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life. | Based on evaluable patient data | Mean | Standard Deviation | units on a scale |
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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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decrease in the NIH-CPSI Total Score by at Least 6 Points | Decrease (improvement) in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. The NIH-CPSI measures the 3 key domains of CP/CPPS: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS. | Posted | Count of Participants | Participants | Baseline and 6 weeks |
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| Secondary | Subscales of the NIH-CPSI | The National Institutes of Health -Chronic Prostatitis Symptom Index (NIH-CPSI) measures the 3 key domains of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A higher score indicates more severe symptoms. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS. | The overall number of participants analyzed in the secondary outcome measures were 210 for the pregabalin arm and 103 for the placebo arm. | Posted | Mean | Standard Deviation | units on the NIH-CPSI scale | 6 weeks |
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| Secondary | Moderately or Markedly Improve on Global Response Assessment (GRA) | The GRA is a 7-question patient self-reported assessment that measures perception of change in symptoms (improvement, no change, or deterioration). The responses are centered at zero (no change in symptoms). Men who reported that they were moderately or markedly improved on a 7-point GRA at the end of the study were identified as treatment responders. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Hospital Anxiety & Depression Scale | Hospital Anxiety and Depression Scale (HADS) (range, 0-42, with higher scores indicating greater anxiety and depression) | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
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| Secondary | McGill Pain Questionnaire | The McGill Pain Questionnaire (MPQ) evaluates the quality of pain as well as the intensity of pain. The McGill Pain Questionnaire ranges from 0-45 for a total pain score, and is the sum of a sensory subscore of 0-33 and affective subscore of 0-12. Higher scores indicate greater pain. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
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| Secondary | Medical Outcomes Study Short Form 12 | Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) (range, 0-100 for the Physical [PCS] and Mental [MCS] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life) | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
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| Secondary | Sexual Health Inventory for Men | Sexual Health Inventory for Men (SHIM) (range, 1-25, with higher scores indicating better sexual function) | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
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6 weeks
Final Adverse Events were reported by arm. They included all AEs by type, regardless of their relationship to study drug.
Patients are counted once in each category and included in the column relating to their worst toxicity grade. Patients may have had events in more than one body system category. An adverse event is not counted if the same event is observed at baseline with an equal or greater toxicity grade.
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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 | 1-Pregabalin | Randomized to Pregabalin | 0 | 218 | 0 | 218 | 129 | 218 |
| EG001 | 2-Placebo | Randomized to placebo | 0 | 106 | 0 | 106 | 62 | 106 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA (6.1) | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Constitutional symptoms | General disorders | MedDRA (6.1) | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Neurologic symptoms | Nervous system disorders | MedDRA (6.1) | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Gastrointestinal disturbance | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Ocular/visual symptoms | Eye disorders | MedDRA (6.1) | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Renal/genitourinary symptoms | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Richard Landis, PhD | University of Pennsylvania | 215-573-4922 | hultman@upenn.edu |
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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