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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197261
• Other study ID #: OXN2503
• Secondary ID: 2009-018118-21
• Status: Completed
• Phase: Phase 2
• Start date: September 2010
• Est. completion date: June 2013

Study information

• Verified date: October 2018
• Source: Mundipharma Research GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Pain
• Painful Bladder Syndrome
• Syndrome

Intervention

Drug:
• Oxycodone naloxone prolonged release tablets
2 tablets/ day
• Placebo tablets
2 tablets/ day

Locations

Country	Name	City	State
United Kingdom	Royal Hallamshire Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research GmbH & Co KG

Countries where clinical trial is conducted

Czechia,  Germany,  Hungary,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the patient's average pain during treatment with OXN PR compared with placebo		8 weeks
Secondary	Patient questionnaires		8 weeks

External Links

•   Results available on website