Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients
Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients
The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged
 release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the
 reduction of the intensity of opioid-induced constipation symptoms in patients treated for
 cancer or non-cancer pain.
Eligible patients with documented cancer or non-cancer pain, either currently receiving a WHO
 step II opioid and requiring the initiation of a WHO step III opioid or currently receiving a
 WHO step III opioid, and having opioid-related constipation defined by either a KESS score ≥9
 or the current use of laxatives (≥3 times per week), will be randomly assigned to receive
 either OXN PR or Oxy PR. Randomisation will be stratified on the cause of pain: cancer or
 non-cancer.

 Any patient having completed the study and wishing to receive OXN PR afterwards may enter an
 optional open extension phase. During this phase, all patients will receive OXN PR and be
 managed as per the usual practice in the center until commercial OXN PR is available in
 France (with a limit of 1 year after Day 28). Adverse events will be assessed at each visit.
Inclusion criteria

 1. Male or female patient aged 18 years or older.

 2. With cancer pain or non-cancer pain such as chronic low back pain, osteoarthritis or
 other.

 3. Either currently receiving a WHO step II opioid and requiring the initiation of a WHO
 step III opioid (due to a lack of efficacy of the step II opioid) expected to last 28
 days or more, or currently receiving a WHO step III opioid expected to last further 28
 days or more.

 4. Having opioid-related constipation defined by either a KESS score ≥ 9 or the current
 use of laxatives (at least 3 times per week).

 5. Able, in the opinion of the Investigator, to comply with the study protocol.

 6. Women of childbearing potential must have a negative urine pregnancy test result at
 inclusion (test under supervision of the investigator) and use an effective birth
 control method. Women of non-childbearing potential must be postmenopausal or
 surgically sterile (hysterectomy and/or bilateral oophorectomy).

 7. Having received oral and written information about the study protocol and signed a
 written, informed consent to participate.

 Exclusion criteria

 1. Pregnancy or breastfeeding.

 2. Known contraindication or hypersensitivity to oxycodone, naloxone, bisacodyl, any
 chemically close substance, and ingredients.

 3. Clinically significant impairment of cardiovascular, respiratory, liver or kidney
 function disease, as determined by medical history, clinical laboratory tests, ECG
 results, and physical examination, that in the opinion of the Investigator may present
 a risk upon exposure to the study medication.

 4. Known or suspected unstable brain or spinal cord metastases that may require changes
 in steroid treatment throughout the duration of the study.

 5. Increased intracranial pressure.

 6. Evidence of clinically significant gastrointestinal disease (e.g., paralytic ileus,
 peritoneal carcinosis), significant structural abnormalities of the gastrointestinal
 tract (e.g., scarring, obstruction etc) either related or not related to the
 underlying cancer or disease progression.

 7. Rheumatoid arthritis, as co-medication may have an impact on the study results,
 especially if co-medication is not stable within the study.

 8. Surgery completed prior to the start of the study, or planned surgery during the study
 that would influence pain or bowel function during the study or preclude completion of
 the study.

 9. Cyclic chemotherapy in the two weeks before inclusion or planned during the study that
 has shown in the past to influence bowel function. Patients having their first cycle
 of chemotherapy during the 2 weeks before the inclusion visit or during the study they
 should not be included in the study.

 10. Radiotherapy that, in the investigators opinion, would influence bowel function or
 pain during the study.

 11. Treatment with an opioid receptor antagonist in the month preceding inclusion.

 12. History of alcohol, opioid or other drug abuse.

 13. Current treatment with another psychoactive drug that, in the opinion of the
 Investigator, may present a risk when associated with an opioid.

 14. Any somatic or psychic condition that, in the opinion of the Investigator, may
 compromise the ability of the patient to understand and comply with the study protocol
 or to provide informed consent to participate.

 15. Patient who participated in a clinical research involving a new chemical entity or an
 experimental drug within 30 days of study entry. Concurrent enrolment in another
 clinical trial is not permitted unless the sole purpose of the other trial at the time
 of the OXN3505 inclusion visit is for long-term follow-up/survival data.