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

This study has been completed.
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG Identifier:
First received: September 7, 2010
Last updated: July 23, 2013
Last verified: July 2013
The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.

Condition Intervention Phase
Interstitial Cystitis
Painful Bladder Syndrome
Drug: Oxycodone naloxone prolonged release tablets
Drug: Placebo tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Mundipharma Research GmbH & Co KG:

Primary Outcome Measures:
  • To estimate the patient's average pain during treatment with OXN PR compared with placebo [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Patient questionnaires [ Time Frame: 8 weeks ]

Enrollment: 120
Study Start Date: September 2010
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OXN PR
Oxycodone Naloxone tablets
Drug: Oxycodone naloxone prolonged release tablets
2 tablets/ day
Placebo Comparator: PLA Drug: Placebo tablets
2 tablets/ day

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01197261

Czech Republic
Prague, Czech Republic
Frankfurt, Germany
Budapest, Hungary
Krakow, Poland
United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Mundipharma Research GmbH & Co KG
  More Information

Responsible Party: Mundipharma Research GmbH & Co KG Identifier: NCT01197261     History of Changes
Other Study ID Numbers: OXN2503
2009-018118-21 ( EudraCT Number )
Study First Received: September 7, 2010
Last Updated: July 23, 2013

Keywords provided by Mundipharma Research GmbH & Co KG:
Severe pain
Bladder Pain Syndrome
Interstitial Cystitis
Painful Bladder Syndrome
Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome

Additional relevant MeSH terms:
Cystitis, Interstitial
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on May 25, 2017