Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)Phase 3CPCRN RCT#2NCT00371033
Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
A Phase 3 study testing Pregabalin in people with Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 11 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Mar 2006to 30 Apr 2008
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has signed and dated the appropriate Informed Consent document.
- Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
Who cannot join
- Participant has continued evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 and ≤ 100,000 CFU/ml in mid-stream urine (VB2), as demonstrated by repeat culture obtained no less than seven (7) days post antibiotic treatment.
- Participant has a calculated creatinine clearance of <60 mL/min.
- Participant has a platelet count <100,000/mm3.
- Participant is allergic to antiepileptic/antiseizure medications.
- Participant has a known allergy or sensitivity to pregabalin (Lyrica®).
- Participant is taking thiazolidinedione antidiabetic agents (i.e. rosiglitazone and pioglitazone).
Show all 18Show fewer
- Participant has New York Heart Association Class III or IV congestive heart failure.
- Participant has a history of thrombocytopenia, or a bleeding diathesis.
- Participant has a history of prostate, bladder or urethral cancer.
- Participant has a history of alcohol abuse.
- Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
- Participant has undergone pelvic radiation or systemic chemotherapy.
- Participant has undergone intravesical chemotherapy.
- Participant has been treated with intravesical BCG.
- Participant has unilateral orchalgia without other pelvic symptoms.
- Participant has an active urethral stricture.
- Participant has a neurological disease or disorder affecting the bladder.
- Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
University of Maryland
Baltimore, Maryland, 21201
Harvard Medical School
Boston, Massachusetts, 02115
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Charles R Drew University of Medicine & Science
Los Angeles, California, 90059
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-1738
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
University of Washington Harborview Medical Center
Seattle, Washington, 98108
Stanford University Medical Center
Stanford, California, 94305-5118
About this study
Official title: A Randomized, Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Read the detailed description
Primary Objectives
- To compare six (6) weeks of treatment with pregabalin versus placebo in CP/CPPS participants with respect to the primary endpoint in the NIH-CPSI
- To evaluate the safety and tolerability of six (6) weeks of pregabalin in CP/CPPS participants
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.
- Being tested
- Pregabalin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
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.
PlaceboDrug
Placebo at same frequency as pregabablin
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Not described Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 6 weeks
Hospital Anxiety & Depression Scale
Hospital Anxiety and Depression Scale (HADS) (range, 0-42, with higher scores indicating greater anxiety and depression)
Measured: 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.
Measured: 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)
Measured: 6 weeks
Sexual Health Inventory for Men
Sexual Health Inventory for Men (SHIM) (range, 1-25, with higher scores indicating better sexual function)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2008
- Study completion30 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John Kusek, PhD, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lee Nyberg, PhD, MD, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371033
- Sponsor's protocol ID
- CPCRN2 Pregabalin
- Other IDs
- U01DK065209
- Acronym
- CPCRN RCT#2
- Status last verified
- Aug 2025
- First submitted
- 31 Aug 2006
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/cpcrn2-rct2/?query=cpcrn2
Publications
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.
PubMed 20876412