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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01197261

Enrollment

120

Registered

2010-09-09

Start date

2010-09-30

Completion date

2013-06-30

Last updated

2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Cystitis, Pain, Painful Bladder Syndrome

Keywords

Severe pain, Bladder Pain Syndrome, Interstitial Cystitis, Painful Bladder Syndrome, Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome

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.

Interventions

DRUGOxycodone naloxone prolonged release tablets

2 tablets/ day

DRUGPlacebo tablets

2 tablets/ day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Patient questionnaires	8 weeks

Countries

Czechia, Germany, Hungary, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026