Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
This study has been completed.
Sponsor:
University of Giessen
Collaborators:
Strathmann AG&Co, Hamburg, Germany
Cernelle, Ängelholm, Sweden
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT00919893
First received: February 10, 2009
Last updated: June 15, 2009
Last verified: June 2009
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Purpose
In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. The purpose of this study is to determine whether Cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Prostatitis Chronic Pelvic Pain Syndrome |
Drug: Cernilton Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome |
Resource links provided by NLM:
Further study details as provided by University of Giessen:
Primary Outcome Measures:
- Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine. [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 139 |
| Study Start Date: | December 1999 |
| Study Completion Date: | January 2004 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cernilton
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
|
Drug: Cernilton
Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 23 mg Extractum Pollens siccatum, 4 mg L-glutamate and 0.23 mg Stigmasterol per capsule for 12 weeks.
|
|
Placebo Comparator: Placebo
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
|
Drug: Placebo
Oral placebo, 2 capsules every 8 hours with identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
|
Detailed Description:
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory CP-CPPS (National Institutes of Health (NIH) type IIIA). Participants were randomized to Cernilton or placebo for 12 weeks and were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) individual domains and total score, the number of leukocytes in post prostatic massage urine, the International Prostate Symptom Score (IPSS) and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- men between 18 and 65 years
- symptoms of pelvic pain for at least 3 months during the 6 months before study entry
- a score in the pain domain of the German validated version of the NIH chronic prostatitis symptom index (NIH-CPSI) of 7 or higher
- leukocytes of 10 or more in post prostate massage urine
Exclusion Criteria:
- urinary tract infection
- acute bacterial or chronic bacterial prostatitis
- history of urethritis with discharge 4 weeks prior to study entry
- a history of epididymitis or sexually transmitted disease
- residual urine volume of more than 50 mL due to bladder outlet obstruction
- indication for or history of prostate surgery including prostate biopsy
- treatment with phytotherapeutic agents
- alpha-blocker agents or antimicrobial substances with prostatic penetration 4 weeks prior to study entry
- treatment with agents influencing intraprostatic hormone metabolism 6 months prior to study entry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919893
Locations
| Germany | |
| Justus-Liebig-University | |
| Giessen, Germany, D-35392 | |
Sponsors and Collaborators
University of Giessen
Strathmann AG&Co, Hamburg, Germany
Cernelle, Ängelholm, Sweden
Investigators
| Principal Investigator: | Wolfgang Weidner, Prof. Dr. | Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany |
More Information
Publications:
| Responsible Party: | Prof. Dr. Wolfgang Weidner, Clinic for Urology and Pediatric Urology, JL-University, Giessen, Germany |
| ClinicalTrials.gov Identifier: | NCT00919893 History of Changes |
| Other Study ID Numbers: | 4015497 |
| Study First Received: | February 10, 2009 |
| Results First Received: | February 10, 2009 |
| Last Updated: | June 15, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Giessen:
|
chronic prostatitis symptom index male inflammatory CP-CPPS |
Cernilton pelvic pain symptoms |
Additional relevant MeSH terms:
|
Pelvic Pain Prostatitis Chronic Disease Somatoform Disorders Pain Signs and Symptoms |
Prostatic Diseases Genital Diseases, Male Disease Attributes Pathologic Processes Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013