Exploratory Study of L.S.E.S.r. (PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in the Treatment of Urinary Symptoms Related to BPH; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospective Study (PERMIN)

NCT01604811 Phase 4 COMPLETED

Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation. The aim of the study is to assess the activity on inflammation biomarkers (serum and urine inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the treatment of urinary symptoms related to BPH. The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.

Details

Lead sponsor	Pierre Fabre Medicament
Phase	Phase 4
Status	COMPLETED
Enrolment	206
Start date	2012-06
Completion	2013-10

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

• Permixon® 160 mg
• Tamsulosine Arrow LP
• Placebo matching Permixon® 160 mg
• Placebo matching Tamsulosine Arrow LP

Primary outcomes

• Change from baseline of Inflammation Biomarkers — Day 1 (baseline), Day 30, Day 90
  "Inflammation biomarkers assay in patients suffering from Benign Prostatic Hyperplasia at Day 1, Day 30 and Day 90 : * Urine inflammation markers \[mRNA (messenger RiboNucleic Acid) and proteins\] on the first urine flow after digital rectal examination * Serum inflammation markers (C-Reactive Protein and Sedimentation Rate) "

Countries

France, Italy, Portugal, Spain