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Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Oxycodone naloxone prolonged release tablets (OXN)
Sponsored by
Mundipharma Research GmbH & Co KG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate improvement in symptoms of constipation, Moderate to severe, chronic non-malignant pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects at least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. Subjects must report constipation caused or aggravated by opioids.

Exclusion Criteria:

  • Females who are pregnant or lactating.
  • Subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study.
  • Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 14, 2006
    Last Updated
    October 19, 2018
    Sponsor
    Mundipharma Research GmbH & Co KG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00412100
    Brief Title
    Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation
    Official Title
    A Randomsied, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of 60-80 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    September 2008 (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 primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.
    Detailed Description
    Patients with a documented history of moderate to severe non-malignant pain that require around-the-clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm. The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain
    Keywords
    A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate improvement in symptoms of constipation, Moderate to severe, chronic non-malignant pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Oxycodone naloxone prolonged release tablets (OXN)
    Primary Outcome Measure Information:
    Title
    To demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.
    Time Frame
    12 weeks with a 6 month open label extension

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female subjects at least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. Subjects must report constipation caused or aggravated by opioids. Exclusion Criteria: Females who are pregnant or lactating. Subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study. Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Oliver Lowenstein
    Organizational Affiliation
    Private Practice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20920236
    Citation
    Lowenstein O, Leyendecker P, Lux EA, Blagden M, Simpson KH, Hopp M, Bosse B, Reimer K. Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials. BMC Clin Pharmacol. 2010 Sep 29;10:12. doi: 10.1186/1472-6904-10-12.
    Results Reference
    derived
    Links:
    URL
    https://www.clinicaltrialsregister.eu/ctr-search/search?query=OXN3001
    Description
    Results available on website

    Learn more about this trial

    Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

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