Phase 3
N=324
Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Bottom Line
View on ClinicalTrials.gov: NCT00371033 ↗Enrolled (actual)
324
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Decrease in the NIH-CPSI Total Score by at Least 6 Points — 103; 38 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in the NIH-CPSI Total Score by at Least 6 Points |
103; 38 | — |
| SECONDARY Subscales of the NIH-CPSI |
19.7; 21.6; 9.1; 10.1; 3.7; 4.0 | — |
| SECONDARY Moderately or Markedly Improve on Global Response Assessment (GRA) |
68; 20 | — |
| SECONDARY Hospital Anxiety & Depression Scale |
12.4; 12.2 | — |
| SECONDARY McGill Pain Questionnaire |
9.6; 12.4 | — |
| SECONDARY Medical Outcomes Study Short Form 12 |
46.9; 44.3; 45.0; 44.6 | — |
| SECONDARY Sexual Health Inventory for Men |
16.4; 17.2 | — |
Summary
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
- 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.
Data sourced from ClinicalTrials.gov (NCT00371033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.