OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
Primary Purpose
Interstitial Cystitis, Painful Bladder Syndrome, Pain
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oxycodone naloxone prolonged release tablets
Placebo tablets
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Severe pain, Bladder Pain Syndrome, Interstitial Cystitis, Painful Bladder Syndrome, Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome
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)
Sites / Locations
- Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
OXN PR
PLA
Arm Description
Oxycodone Naloxone tablets
Outcomes
Primary Outcome Measures
To estimate the patient's average pain during treatment with OXN PR compared with placebo
Secondary Outcome Measures
Patient questionnaires
Full Information
NCT ID
NCT01197261
First Posted
September 7, 2010
Last Updated
October 19, 2018
Sponsor
Mundipharma Research GmbH & Co KG
1. Study Identification
Unique Protocol Identification Number
NCT01197261
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research GmbH & Co KG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OXN PR
Arm Type
Active Comparator
Arm Description
Oxycodone Naloxone tablets
Arm Title
PLA
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxycodone naloxone prolonged release tablets
Intervention Description
2 tablets/ day
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Intervention Description
2 tablets/ day
Primary Outcome Measure Information:
Title
To estimate the patient's average pain during treatment with OXN PR compared with placebo
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Patient questionnaires
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
City
Prague
Country
Czechia
City
Frankfurt
Country
Germany
City
Budapest
Country
Hungary
City
Krakow
Country
Poland
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=OXN2503
Description
Results available on website
Learn more about this trial
OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
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