OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
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.
2 other identifiers
interventional
120
5 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2010
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 7, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 23, 2018
October 1, 2018
2.5 years
September 7, 2010
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To estimate the patient's average pain during treatment with OXN PR compared with placebo
8 weeks
Secondary Outcomes (1)
Patient questionnaires
8 weeks
Study Arms (2)
OXN PR
ACTIVE COMPARATOROxycodone Naloxone tablets
PLA
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Prague, Czechia
Unknown Facility
Frankfurt, Germany
Unknown Facility
Budapest, Hungary
Unknown Facility
Krakow, Poland
Royal Hallamshire Hospital
Sheffield, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2010
First Posted
September 9, 2010
Study Start
September 1, 2010
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
October 23, 2018
Record last verified: 2018-10