Randomized, open label, comparative parallel group study to assess efficacy and safety of flexible dosages of OROS hydromorphone once-daily compared to sustained release oxycodone twice-daily in subjects with chronic non-malignant pain requiring continuous opioid therapy

Phase 1

• Conditions: Chronic non-malignant pain

• Registration Number: EUCTR2004-005187-24-SK
• Lead Sponsor: Janssen-Cilag Medical Affaires EMEA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-30
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

Male and female subjects with chronic non-malignant pain severe enough to require continuous opioid therapy such as:chronic low back pain, musculoskeletal pain such as osteoarthritis, rheumatoid arthritis, neuropathic pain like post-herpetic neuralgia, diabetic polyneuropathia, other chronic pain conditions usually responsive to opioid treatment like peripheral arterial occlusion disease, phantom limb pain or chronic pancreatitis.Subjects, who are currently treated with non-opioids or with weak opioids such as codein, dihydrocodeine or tramadol.Subjects with rheumatoid arthritis, who are on a stable dosage of DMARDS.Age 18 years or more.Subjects with chronic pain from which they have been suffering for more than 3 months for at least 20 days per month.Subjects who experience currently insufficient pain control, with a baseline score of 5 or more on item _pain right now_ on a 11 point numeric rating scale.Subjects must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who have previously failed on hydromorphone or oxycodone therapy or those who previously have discontinued hydromorphone or oxycodone due to adverse events.Subjects with known hypersensitivity to hydromorphone or oxycodone.Subjects unable to swallow OROS® hydromorphone or SR oxycodone.Subjects who are currently treated with strong opioids (morphine, buprenorphine, fentanyl, hydromorphone, levomethadone, oxycodone, pentacocine, piritramide, remifentanil, sufentanil, diamorphine) within the last 4 weeks prior to study inclusion.Subjects with chronic pain due to conditions, where opioid treatment is not established, like fibromyalgia, complex regional pain syndrome, migraine and other types of headache or psychogenic pain.Subjects with a history of significant cardiac, nervous system (epilepsy or increased intracranial pressure), respiratory disease (chronic obstructive airways disease, cor pulmonale or chronic bronchial asthma), gastrointestinal (stenosis, paralytic ileus, chronic constipation, delayed gastric emptying or abdominal surgery within the last month), moderate to severe hepatic impairment, severe renal impairment (creatinine clearance <10 ml/min) or hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.Subjects with any risk factor, in the investigator's judgment, bearing a potential for respiratory depression.Subjects with a significant psychiatric disorder (including depression) or subjects receiving anti-psychotic medication.Subjects with a history of disallowed therapies (concurrent administration of monoamine oxidase inhibitors or within last 2 weeks, neuroleptics (exception: haloperidol or DHB), tri-cyclic antidepressants (other classes of ADs are allowed if solely used as pain treatment), hypnotics (exception: short acting hypnotics taken for sleep induction for up to 30 days during the course of the trial), sympathomimetic drugs, tetrabenazines, drugs acting at central dopamine receptors (levodopa and dopamine agonists).Subjects who started topical analgesic medications, anesthetics and/or muscle relaxants within 2 week prior to study inclusion.Subjects who started a treatment, which may influence pain severity (e.g. corticosteroids) within 2 week prior to study inclusion.Subjects with rheumatoid arthritis, who recently started treatment with DMARDS and have not yet received a stable dosage.Subjects with other diseases which would, in the opinion of the investigator, prevent participation in this study·Life-threatening diseases, including: malignant diseases, known HIV positivity and AIDS.Subjects who, at entry, are known to have treatment planned within the next 6 months, which may abruptly alter the degree or nature of pain experienced such that the strong opioid will no longer be necessary (e.g. neurological techniques, surgery, disease modifying medical treatment).Pregnancy or breast-feeding females.Females of childbearing potential without adequate contraception (e.g. oral/IM contraceptive or IUCD) unless sexually abstinent.History of alcohol or drug abuse in the preceding 12 months or actual diagnosis.Participation in an investigational drug trial in the 30 days prior to selection or current inclusion in any other trial or research project;Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical trial or will not comply with requirements of the study.Subjects who are employed at the study center or the

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified