A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
This trial is active, not recruiting.
|Treatments||oxycodone/naloxone prolonged release (oxn pr) tablets, oxycodone prolonged release (oxypr) tablets|
|Sponsor||Mundipharma Research GmbH & Co KG|
|Start date||September 2011|
|End date||February 2014|
|Trial size||270 participants|
|Trial identifier||NCT01438567, 2010-021995-27, OXN3506|
The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Bowel function Index (BFI)
time frame: 5 weeks and a 6 month extension
Pain Intensity Scale (PIS)
time frame: 5 weeks
Male or female participants at least 18 years old.
Inclusion Criteria - Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain. - Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy Exclusion Criteria - Females who are pregnant or lactating. - Subjects with evidence or significant structural abnormalities of the gastrointestinal tract. - Subjects with evidence of impaired liver/kidney function upon entry into the study.
|Official title||A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone|
|Description||The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.|
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