OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Pain, Interstitial Cystitis, Painful Bladder Syndrome

Intervention / Treatment
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* Drug: Oxycodone naloxone prolonged release tablets
* Drug: Placebo tablets


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OXN PR<br>Oxycodone Naloxone tablets | Drug: Oxycodone naloxone prolonged release tablets<br>* 2 tablets/ day<br>|
| Placebo Comparator: PLA<br> | Drug: Placebo tablets<br>* 2 tablets/ day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the patient's average pain during treatment with OXN PR compared with placebo |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient questionnaires |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe pain, Bladder Pain Syndrome, Interstitial Cystitis, Painful Bladder Syndrome, Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome