Clinical trial NCT01197261: OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
Official title: An Exploratory, Randomised, Double-blind, Placebo-controlled, Parallel Group, Pilot Study to Assess the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets (OXN PR) Compared to Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Interstitial Cystitis
Painful Bladder Syndrome
Pain
Keywords: Severe pain
Bladder Pain Syndrome
Interstitial Cystitis
Painful Bladder Syndrome
Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome
Lead sponsor: Mundipharma Research GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* History of severe pain due to Bladder Pain Syndrome (BPS) for at least 6 months
* Subject's treatment of pain due to BPS is insufficient
* Subjects must not have received opioid containing medication in the last 6 months

Exclusion Criteria:

* Females who are pregnant or lactating
* Subjects with any contraindication/history of hypersensitivity to oxycodone, naloxone, paracetamol, related products or other ingredients
* Subjects with any situation in which opioids are contraindicated like severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma or paralytic ileus
* Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results
* Abnormal aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatise levels (\> 3 times the upper limit of normal), gamma glutamyl transpeptidase \> 3 times the upper limit of normal
* Abnormal total bilirubin and/or creatinine level(s)

Primary outcomes:
measure: To estimate the patient's average pain during treatment with OXN PR compared with placebo
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient questionnaires
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
city: Frankfurt
country: Germany
city: Budapest
country: Hungary
city: Krakow
country: Poland
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
References: