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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-06-30

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.

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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.

Conditions

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Interstitial Cystitis Painful Bladder Syndrome Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OXN PR

Oxycodone Naloxone tablets

Group Type ACTIVE_COMPARATOR

Oxycodone naloxone prolonged release tablets

Intervention Type DRUG

2 tablets/ day

PLA

Group Type PLACEBO_COMPARATOR

Placebo tablets

Intervention Type DRUG

2 tablets/ day

Interventions

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Oxycodone naloxone prolonged release tablets

2 tablets/ day

Intervention Type DRUG

Placebo tablets

2 tablets/ day

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No