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

Phase 2

Completed

• Conditions: Pain; Interstitial Cystitis; Painful Bladder Syndrome
• Interventions: Drug: Oxycodone naloxone prolonged release tablets; Drug: Placebo tablets

• Registration Number: NCT01197261
• Lead Sponsor: Mundipharma Research GmbH & Co KG

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OXN PR	Oxycodone naloxone prolonged release tablets	Oxycodone Naloxone tablets
PLA	Placebo tablets	-

Primary Outcome Measures

Name	Time	Method
To estimate the patient's average pain during treatment with OXN PR compared with placebo	8 weeks

Secondary Outcome Measures

Name	Time	Method
Patient questionnaires	8 weeks

Trial Locations

Locations (1)

Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom