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