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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00992576
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : February 15, 2012
Information provided by:
Mundipharma Research GmbH & Co KG

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

Condition or disease Intervention/treatment Phase
Constipation Drug: Active Hydromorphone PR + Active Naloxone PR Drug: Active Hydromorphone PR + Placebo Naloxone PR Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2010
Primary Completion Date : November 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Active Hydromorphone PR + Active Naloxone PR
    Optimal pain relief and improved bowel function in constipated pain patients
    Drug: Active Hydromorphone PR + Placebo Naloxone PR
    Optimal pain relief and improved bowel function in constipated pain patients

Primary Outcome Measures :
  1. Bowel Function Measure Average pain scores

Secondary Outcome Measures :
  1. Bowel Function Measures Rescue medication use

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992576

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

ClinicalTrials.gov Identifier: NCT00992576     History of Changes
Other Study ID Numbers: 2008-005312-18
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012

Keywords provided by Mundipharma Research GmbH & Co KG:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Central Nervous System Depressants