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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Hydromorphone PR + Active Naloxone PR | Drug | Optimal pain relief and improved bowel function in constipated pain patients | ||
| Active Hydromorphone PR + Placebo Naloxone PR | Drug | Optimal pain relief and improved bowel function in constipated pain patients |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Function Measure Average pain scores |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Function Measures Rescue medication use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter New England Area Health Service | Newcastle | New South Wales | 2300 | Australia | ||
| AKH Wien - Universitätskliniken |
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| Vienna |
| A-1090 |
| Austria |
| Erasme Hospital | Brussels | 1070 | Belgium |
| Poradna pro lecbu bolesti | Příbram | 261-01 | Czechia |
| Speciallæge Michael Crawford | København K. | 1100 | Denmark |
| Oma Lääkäri Oy | Kuopio | Fl-70100 | Finland |
| CHU - Hôpital Amiens Nord | Amiens | 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 |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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