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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 11
- 主要终点
- Decrease in the NIH-CPSI Total Score by at Least 6 Points
研究概览
简要总结
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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/mm
- •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.
研究组 & 干预措施
Pregabalin
干预措施: Pregabalin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Decrease in the NIH-CPSI Total Score by at Least 6 Points
时间窗: Baseline and 6 weeks
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.
次要结局
- Subscales of the NIH-CPSI(6 weeks)
- Moderately or Markedly Improve on Global Response Assessment (GRA)(6 weeks)
- Hospital Anxiety & Depression Scale(6 weeks)
- McGill Pain Questionnaire(6 weeks)
- Medical Outcomes Study Short Form 12(6 weeks)
- Sexual Health Inventory for Men(6 weeks)