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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.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT01197261
First received: September 7, 2010
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Pain
 Drug: Oxycodone naloxone prolonged release tablets
Drug: Placebo tablets
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient questionnaires [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2010
Study Completion Date: March 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197261

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

No publications provided

Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT01197261     History of Changes
Other Study ID Numbers: OXN2503, 2009-018118-21
Study First Received: September 7, 2010
Last Updated: March 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy

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
Pain
Cystitis, Interstitial
Stress, Psychological
Urinary Bladder Diseases
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Naloxone
Oxycodone
 Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on May 16, 2013