A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain

NCT ID: NCT01971632

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 463 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2006-05-31

Brief Summary

The primary objective was to demonstrate the superiority of OXN over placebo over time from the initial dose of study medication to multiple pain events (inadequate analgesia) during the double blind phase.

Conditions

Subjects With Moderate to Severe, Chronic Nonmalignant Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Oxycodone/Naloxone

Group Type: ACTIVE_COMPARATOR

Oxycodone & naloxone combination, prolonged release

Intervention Type: DRUG

Placebo oxycodone/naloxone

Group Type: PLACEBO_COMPARATOR

placebo oxycodone / naloxone

Intervention Type: DRUG

Interventions

Oxycodone & naloxone combination, prolonged release

Intervention Type: DRUG

placebo oxycodone / naloxone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects had to meet all the following criteria to be included in this study:

1. Males and females at least 18 years of age (Females less than one year post-menopausal had to have a negative serum or urine pregnancy test recorded within 72 hours prior to the first dose of study medication, be non-lactating, and willing to use adequate and reliable contraception throughout the study.).

2. Documented history of moderate to severe chronic pain of low back that required around-the-clock opioid therapy.

3. Nonmalignant low back pain adequately managed by an opioid analgesic for at least the past 2 weeks.

4. Subjects who required continuation of daily opioid analgesic treatment and were likely to benefit from chronic opioid therapy for the duration of the study.

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

• Bullet 3: Nonmalignant low back pain (for example osteoarthrosis / osteoarthritis of spine, deforming spondylosis, spondylolisthesis, disc herniation / sciatica, spinal stenosis) adequately managed by an opioid analgesic for at least the past 2 weeks.
• Bullet 4: Subjects who required continuation of daily opioid analgesic treatment and were likely to benefit from chronic opioid therapy (WHO step III opioid) for the duration of the study.

Exclusion Criteria

Subjects who met any of the following criteria were excluded from this study:

1. Any history of hypersensitivity to oxycodone, naloxone, or related products.

2. Subjects currently taking the equivalent of < 10 mg or > 40 mg/d oxycodone (Refer to Appendix 12.2 of the protocol: Drug Conversion Tables.).

3. Subjects diagnosed with cancer, not including basal cell carcinoma.

4. Active alcohol or drug abuse with severity sufficient to place the subjects at risk.

5. Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, Electrocardiogram (ECG) results, and physical examination, that would have placed the subject at risk upon exposure to the study medication or that could confound the analysis and/or interpretation of the study results.

6. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (> 3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (outside of the reference range).

7. Surgery completed less than 2 months prior to the start of the Screening Period, planned surgery during the 12-week Double-blind Phase, or any other pharmacological or non-pharmacological intervention that would have influenced pain during the study (not including chemotherapy) or precluded completion of the study.

8. Subjects taking, or who had taken, naloxone or an experimental drug less than 30 days prior to the start of the Screening Period.

9. Subjects with a history of 2 or greater low back surgeries. Amendment No. 1, dated 28-Sep-2004 prior to FPFV, changed the exclusion criterion bullet 4 to: Active alcohol or drug abuse.

Amendment No. 2, dated 25-May-2005, changed the exclusion criterion bullet 9 to: Subjects with a history of less than 2 low back surgeries.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma Research GmbH & Co KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/search?query=OXN3401

Results available on website

Other Identifiers

OXN3401

Identifier Type: -

Identifier Source: org_study_id