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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01197261
• Date of registration: 07/09/2010
• Prospective Registration: No
• Primary sponsor: Mundipharma Research GmbH & Co KG
• Public title: OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
• Scientific 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.
• Date of first enrolment: September 2010
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01197261
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Czech Republic, Czechia, Germany, Hungary, Poland, United Kingdom

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Interstitial Cystitis

Pain

Painful Bladder Syndrome

Intervention(s)

Drug: Oxycodone naloxone prolonged release tablets

Drug: Placebo tablets

Primary Outcome(s)

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

Secondary Outcome(s)

Patient questionnaires [Time Frame: 8 weeks]

Secondary ID(s)

2009-018118-21

OXN2503

Source(s) of Monetary Support

Please refer to primary and secondary sponsors