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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Active Hydromorphone PR + Active Naloxone PR
Active Hydromorphone PR + Placebo Naloxone PR
Sponsored by
Mundipharma Research GmbH & Co KG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Confirmatory, Constipation, Pain, Hydromorphone, Naloxone

Eligibility Criteria

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

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.

Sites / Locations

  • Hunter New England Area Health Service
  • AKH Wien - Universitätskliniken
  • Erasme Hospital
  • Poradna pro lecbu bolesti
  • Speciallæge Michael Crawford
  • Oma Lääkäri Oy
  • CHU - Hôpital Amiens Nord
  • Universitaetsklinikum Jena
  • Tel-Aviv Sourasky Medical Center
  • Diakonessenhuis, locatie Zeist
  • Szpital Uniwersytecki w Krakowie Zakład Badania
  • Spitalul Clinic Judetean de Urgenta Cluj
  • Kantonsspital Aarau
  • Avondale Surgery

Outcomes

Primary Outcome Measures

Bowel Function Measure Average pain scores

Secondary Outcome Measures

Bowel Function Measures Rescue medication use

Full Information

First Posted
October 6, 2009
Last Updated
February 14, 2012
Sponsor
Mundipharma Research GmbH & Co KG
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1. Study Identification

Unique Protocol Identification Number
NCT00992576
Brief Title
Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
Acronym
HMX3501
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mundipharma Research GmbH & Co KG

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Confirmatory, Constipation, Pain, Hydromorphone, Naloxone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Active Hydromorphone PR + Active Naloxone PR
Intervention Description
Optimal pain relief and improved bowel function in constipated pain patients
Intervention Type
Drug
Intervention Name(s)
Active Hydromorphone PR + Placebo Naloxone PR
Intervention Description
Optimal pain relief and improved bowel function in constipated pain patients
Primary Outcome Measure Information:
Title
Bowel Function Measure Average pain scores
Secondary Outcome Measure Information:
Title
Bowel Function Measures Rescue medication use

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 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). Subjects with constipation caused or aggravated by opioids Subjects must be willing to discontinue their current opioid analgesic routine, and . current laxative regimen Exclusion Criteria: Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis. Subjects presently taking, or who have taken, naloxone <=30 days prior to the start of the Screening Period. Subjects suffering from diarrhoea. Abnormal liver or kidney function.
Facility Information:
Facility Name
Hunter New England Area Health Service
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
Facility Name
AKH Wien - Universitätskliniken
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Erasme Hospital
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Poradna pro lecbu bolesti
City
Pribram
ZIP/Postal Code
261-01
Country
Czech Republic
Facility Name
Speciallæge Michael Crawford
City
København K.
ZIP/Postal Code
1100
Country
Denmark
Facility Name
Oma Lääkäri Oy
City
Kuopio
ZIP/Postal Code
Fl-70100
Country
Finland
Facility Name
CHU - Hôpital Amiens Nord
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Universitaetsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Diakonessenhuis, locatie Zeist
City
Zeist
ZIP/Postal Code
3707HL
Country
Netherlands
Facility Name
Szpital Uniwersytecki w Krakowie Zakład Badania
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Avondale Surgery
City
Chesterfield
ZIP/Postal Code
S40 4TF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

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