Clinical trial NCT01167699 (phase 3, status: completed)
Conditions: pain
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52
Drugs: oxycodone and naloxone
SMILES: OC1=CC=C2C[C@H]3N(CC=C)CC[C@@]45[C@@H](OC1=C24)C(=O)CC[C@@]35O
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients at least 18 years or older with moderate to severe
             non-malignant pain who are willing to provide written informed consent.

          2. Females less than one year post-menopausal must have a negative urine pregnancy test
             recorded at the screening visit, be non-lactating, and willing to use adequate and
             reliable contraception throughout the study. Highly effective methods of birth control
             are defined as those which result in a low failure rate (i.e. less than 1% per year)
             when used consistently and correctly such as sterilisation, implants, injectables,
             combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual
             abstinence or vasectomised partner.

          3. Patients with documented history of moderate to severe, non-malignant pain treated
             with WHO step I or II analgesics with insufficient pain relief and/or unacceptable
             side effects that requires around-the-clock opioid therapy (starting dose of oxycodone
             over 20 mg/day) and are likely to benefit from WHO step III opioid therapy for the
             duration of the study. Patients must be willing to discontinue their current
             analgesics, like opioids. Co-analgesics, such as anti-depressants and anti-epileptics,
             can be continued provided that the co-analgesics are used on a stable dose before and
             during the study.

          4. Patients are willing to discontinue pre study laxative medication.

          5. Patients taking daily fibre supplementation or bulking agents are eligible if they can
             be maintained on a stable dose and regimen throughout the study, and in the
             investigators opinion are willing and able to maintain adequate hydration.

          6. Patients willing and able to participate in all aspects of the study, including use of
             medication, completion of subjective evaluations, attending scheduled clinic visits,
             completing telephone contacts, and compliance with protocol requirements as evidenced
             by providing written, informed consent.

        Exclusion Criteria:

          1. Any history of hypersensitivity to oxycodone, naloxone, related products, and other
             ingredients.

          2. Patients that require a dose over 20 mg/day oxycodone at the start of the study.

          3. Active alcohol or drug abuse and/or history of opioid abuse.

          4. Evidence of clinically significant cardiovascular, renal, hepatic, or psychiatric
             disease, as determined by medical history, clinical laboratory tests, ECG results, and
             physical examination, that would place the patient at risk upon exposure to the study
             medication or that may confound the analysis and/or interpretation of the study
             results.

          5. In the investigator's opinion, patients who are receiving hypnotics or other central
             nervous system (CNS) depressants that may pose a risk of additional CNS depression
             with opioid study medication.

          6. Patients receiving opioid substitution therapy for opioid addiction (e.g., methadone
             or buprenorphine).

          7. Patients with uncontrolled seizures or convulsive disorder.

          8. Patients who have a confirmed diagnosis of ongoing irritable bowel syndrome.

          9. Patients with evidence of clinically significant gastrointestinal disease (e.g.
             paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the
             gastrointestinal tract (e.g. scarring, obstruction etc).

         10. Patients who participated in a clinical research study involving a new chemical entity
             or an experimental drug within 30 days of study entry.

         11. 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.

         12. Patients presently taking, or who have taken, naloxone <30 days prior to the start of
             the study.

         13. Patients suffering from diarrhoea and/or opioid withdrawal.

         14. Patients with any situation in which opioids are contra-indicated, severe respiratory
             depression with hypoxia and/or hypercapnia, severe obstructive pulmonary disease, cor
             pulmonale, severe bronchial asthma, paralytic ileus.

         15. Patients with myxodema, hypothyroidism, Addisons disease, increase of intracranial
             pressure and/or epilepsy (see also exclusion criteria 7).