A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects
Severe Chronic Pain
About this trial
This is an interventional treatment trial for Severe Chronic Pain focused on measuring oxycodone naloxone combination, severe chronic pain, non-malignant pain, Non-malignant pain that requires around-the-clock opioid therapy
Eligibility Criteria
Inclusion Criteria:
Subjects who are receiving WHO step II/III opioid analgesic medication for the treatment of non-malignant pain and who require daily opioid treatment for pain with WHO step III opioid therapy for the duration of the study, based on Investigator's judgement.
Documented history of non-malignant pain that requires around-the-clock opioid therapy (20 - 50 mg oxycodone PR equivalent per day for a minimum of study duration).
Subjects with constipation caused or aggravated by opioids:
- Subject's medical need of regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations when not taking a laxative.
- In the opinion of the subject and investigator confirm that the subject's constipation is induced, or worsened by the subject's prestudy opioid medication (present at Screening).
Exclusion Criteria:
Any contraindication to oxycodone, naloxone, or any non-investigational medicinal products (NIMPs) that will be used by subjects during the study.
Continuous systemic use of antibiotics and/or steroids within the last 4 weeks prior to the start of the Screening Period and during the study period.
Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis
Sites / Locations
- Gemeinschaftspraxis Loewenstein
- Dr J Hafer
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
OXN PR followed by OxyPR tablets
OxyPR followed by OXN PR tablets
OXN PR followed by OxyPR tablets
OxyPR followed by OXN PR tablets