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

October 19, 2018 updated by: Mundipharma Research GmbH & Co KG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks with a 6 month open label extension

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma Research GmbH & Co KG

Investigators

  • Principal Investigator: Oliver Lowenstein, Private Practice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

December 14, 2006

First Submitted That Met QC Criteria

December 14, 2006

First Posted (ESTIMATE)

December 15, 2006

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXN3006
  • 2005-003510-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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