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
18 Years
N/A
Both
Pain, Constipation
Trial Information
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
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.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Bowel function Index (BFI)
Outcome Description:
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
Outcome Time Frame:
5 weeks and a 6 month extension
Safety Issue:
No
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
OXN3506
NCT ID:
NCT01438567
Start Date:
September 2011
Completion Date:
December 2013
Related Keywords:
- Pain
- Constipation
- oxycodone naloxone combination
- severe chronic and non-malignant pain
- Malignant and non-malignant pain that requires around-the clock opioid therapy
- Opioid related constipation
- Constipation
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