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Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

Information source: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Constipation

Intervention: Active Hydromorphone PR + Active Naloxone PR (Drug); Active Hydromorphone PR + Placebo Naloxone PR (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Mundipharma Research GmbH & Co KG


The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an

improved bowel function for constipated pain patients.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Bowel Function Measure Average pain scores

Secondary outcome: Bowel Function Measures Rescue medication use

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

AKH Wien - Universitätskliniken, Wien A-1090, Austria

Erasme Hospital, Bruxelles 1070, Belgium

Poradna pro lecbu bolesti, Pribram 261-01, Czech Republic

Speciallæge Michael Crawford, København K. 1100, Denmark

Oma Lääkäri Oy, Kuopio Fl-70100, Finland

CHU - Hôpital Amiens Nord, Amiens Cedex 1 80054, France

Universitaetsklinikum Jena, Jena 07747, Germany

Tel-Aviv Sourasky Medical Center, Tel Aviv 64239, Israel

Diakonessenhuis, locatie Zeist, Zeist 3707HL, Netherlands

Szpital Uniwersytecki w Krakowie Zakład Badania, Krakow 31-531, Poland

Spitalul Clinic Judetean de Urgenta Cluj, Cluj-Napoca 400006, Romania

Kantonsspital Aarau, Aarau 5001, Switzerland

Avondale Surgery, Chesterfield S40 4TF, United Kingdom

Hunter New England Area Health Service, Newcastle, New South Wales 2300, Australia

Additional Information

Starting date: January 2010
Last updated: February 14, 2012

Page last updated: August 23, 2015

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