The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
Optimal pain relief and improved bowel function in constipated pain patients
Optimal pain relief and improved bowel function in constipated pain patients
Hunter New England Area Health Service
Newcastle, New South Wales, Australia
AKH Wien - Universitätskliniken
Vienna, Austria
Erasme Hospital
Brussels, Belgium
Bowel Function Measure Average pain scores
Bowel Function Measures Rescue medication use
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Poradna pro lecbu bolesti
Příbram, Czechia
Speciallæge Michael Crawford
København K., Denmark
Oma Lääkäri Oy
Kuopio, Finland
CHU - Hôpital Amiens Nord
Amiens, France
Universitaetsklinikum Jena
Jena, Germany
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Diakonessenhuis, locatie Zeist
Zeist, Netherlands
...and 4 more locations