Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain (HMX3501)

February 14, 2012 updated by: Mundipharma Research GmbH & Co KG

A Confirmatory, Placebo-controlled, Randomised, Double-blind, Single-dummy, Parallel Group, Ratio-finding Study in Constipated Pain Patients to Establish an Optimal Hydromorphone - Naloxone Ratio With an Improved Bowel Function and a Comparable Analgesic Efficacy Compared to Hydromorphone Alone

The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects suffering from cancer or non-cancer pain suffering from constipation cased or aggravated by opioids will be randomised to one of four ratios of hydromorphone PR plus naloxone PR or Hydromorphone PR plus placebo to investigate whether a hydromorphone/naloxone combination will lead to comparable analgesia, with a decrease in constipation, and to investigate the optimal dose ratio of hydromorphone and naloxone.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2300
        • Hunter New England Area Health Service
  • Austria
      • Wien, Austria, A-1090
        • AKH Wien - Universitätskliniken
  • Belgium
      • Bruxelles, Belgium, 1070
        • Erasme Hospital
  • Czech Republic
      • Pribram, Czech Republic, 261-01
        • Poradna pro lecbu bolesti
  • Denmark
      • København K., Denmark, 1100
        • Speciallæge Michael Crawford
  • Finland
      • Kuopio, Finland, Fl-70100
        • Oma Lääkäri Oy
  • France
      • Amiens Cedex 1, France, 80054
        • CHU - Hôpital Amiens Nord
  • Germany
      • Jena, Germany, 07747
        • Universitaetsklinikum Jena
  • Israel
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
  • Netherlands
      • Zeist, Netherlands, 3707HL
        • Diakonessenhuis, locatie Zeist
  • Poland
      • Krakow, Poland, 31-531
        • Szpital Uniwersytecki w Krakowie Zakład Badania
  • Romania
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Judetean de urgenta Cluj
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau
  • United Kingdom
      • Chesterfield, United Kingdom, S40 4TF
        • Avondale Surgery

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:

  1. Male or female subjects at least 18 years with a history of non-cancer or cancer pain that requires around-the-clock opioid therapy (8, 24 or 48 mg hydromorphone PR per day for the duration of the study).
  2. Subjects with constipation caused or aggravated by opioids
  3. Subjects must be willing to discontinue their current opioid analgesic routine, and .
  4. current laxative regimen

Exclusion Criteria:

  1. Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis.
  2. Subjects presently taking, or who have taken, naloxone <=30 days prior to the start of the Screening Period.
  3. Subjects suffering from diarrhoea.
  4. Abnormal liver or kidney function.

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
Bowel Function Measure Average pain scores

Secondary Outcome Measures

Outcome Measure
Bowel Function Measures Rescue medication use

Collaborators and Investigators

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

Sponsor

Mundipharma Research GmbH & Co KG

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

January 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

October 6, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (ESTIMATE)

October 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-005312-18

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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