Status:
COMPLETED
OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
Lead Sponsor:
Mundipharma Research GmbH & Co KG
Conditions:
Interstitial Cystitis
Painful Bladder Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 f...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01197261
Start Date
September 1 2010
End Date
June 1 2013
Last Update
October 23 2018
Active Locations (5)
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1
Prague, Czechia
2
Frankfurt, Germany
3
Budapest, Hungary
4
Krakow, Poland