NCT01197261

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Mundipharma Research GmbH & Co KG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interstitial Cystitis
• Painful Bladder Syndrome
• Pain

Interventions

Type	Name	Description
DRUG	Oxycodone naloxone prolonged release tablets	2 tablets/ day
DRUG	Placebo tablets	2 tablets/ day

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2010-09-09
• Last updated: 2018-10-23

Locations

5 sites across 5 countries: Czechia, Germany, Hungary, Poland, United Kingdom