Trial Outcomes & Findings for Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS) (NCT NCT00919893)
NCT ID: NCT00919893
Last Updated: 2020-11-20
Results Overview
Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
139 participants
Primary outcome timeframe
0, 6, 12 weeks
Results posted on
2020-11-20
Participant Flow
Outpatients at urologic clinics. Start date: December 1999. Stop date: January 2004.
Participant milestones
| Measure |
Cernilton
Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
|
Placebo
Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
69
|
|
Overall Study
COMPLETED
|
51
|
60
|
|
Overall Study
NOT COMPLETED
|
19
|
9
|
Reasons for withdrawal
| Measure |
Cernilton
Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
|
Placebo
Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
19
|
9
|
Baseline Characteristics
Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
Baseline characteristics by cohort
| Measure |
Cernilton
n=70 Participants
Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
|
Placebo
n=69 Participants
Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
70 participants
n=5 Participants
|
69 participants
n=7 Participants
|
139 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 6, 12 weeksPopulation: ITT (Intention to treat) LOCF (Last observation carried forward)
Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.
Outcome measures
| Measure |
Cernilton
n=70 Participants
Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
|
Placebo
n=69 Participants
Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
|
|---|---|---|
|
Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
|
47 participants
|
33 participants
|
SECONDARY outcome
Timeframe: 0, 6, 12 weeksDecrease of score points. Decrease of leucocytes in urine.
Outcome measures
| Measure |
Cernilton
n=70 Participants
Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
|
Placebo
n=69 Participants
Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
|
|---|---|---|
|
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.
|
47 participants
|
33 participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. F.M.E. Wagenlehner
Clinic for urology and pediatric urology, JL-University, Giessen, Germany
Phone: 0049 641 9944518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place