The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.
The study consists of a screening period followed by randomisation of the patients in a 1:1 ratio to OXN PR treatment or placebo treatment in a double blind fashion. The double blind phase will last for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
2 tablets/ day
2 tablets/ day
Unnamed facility
Prague, Czechia
Unnamed facility
Frankfurt, Germany
Unnamed facility
Budapest, Hungary
Unnamed facility
Krakow, Poland
Royal Hallamshire Hospital
Sheffield, United Kingdom
To estimate the patient's average pain during treatment with OXN PR compared with placebo
Time frame: 8 weeks
Patient questionnaires
Time frame: 8 weeks
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