search
Back to results

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

Primary Purpose

Interstitial Cystitis, Painful Bladder Syndrome, Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oxycodone naloxone prolonged release tablets
Placebo tablets
Sponsored by
Mundipharma Research GmbH & Co KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Severe pain, Bladder Pain Syndrome, Interstitial Cystitis, Painful Bladder Syndrome, Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OXN PR

PLA

Arm Description

Oxycodone Naloxone tablets

Outcomes

Primary Outcome Measures

To estimate the patient's average pain during treatment with OXN PR compared with placebo

Secondary Outcome Measures

Patient questionnaires

Full Information

First Posted
September 7, 2010
Last Updated
October 19, 2018
Sponsor
Mundipharma Research GmbH & Co KG
search

1. Study Identification

Unique Protocol Identification Number
NCT01197261
Brief Title
OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research GmbH & Co KG

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Painful Bladder Syndrome, Pain
Keywords
Severe pain, Bladder Pain Syndrome, Interstitial Cystitis, Painful Bladder Syndrome, Severe pain due to Bladder Pain Syndrome/Interstitial Cystitis/Painful Bladder Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OXN PR
Arm Type
Active Comparator
Arm Description
Oxycodone Naloxone tablets
Arm Title
PLA
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxycodone naloxone prolonged release tablets
Intervention Description
2 tablets/ day
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Intervention Description
2 tablets/ day
Primary Outcome Measure Information:
Title
To estimate the patient's average pain during treatment with OXN PR compared with placebo
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Patient questionnaires
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
City
Prague
Country
Czechia
City
Frankfurt
Country
Germany
City
Budapest
Country
Hungary
City
Krakow
Country
Poland
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=OXN2503
Description
Results available on website

Learn more about this trial

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

We'll reach out to this number within 24 hrs