A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis

NCT00784810 | Completed Phase 4 Results

• 1 other identifier: OXN4502 (2008-002426-10)
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare oxycodone/naloxone combination tablet and codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or pain due to osteoarthritis.

Conditions

Osteoarthritis; Back Pain

Keywords

Efficacy, tolerability, moderate/severe, oxycodone/naloxone; codeine/paracetamol, chronic low back pain, osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)

  The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)

  Average daily pain over last 24 hours (at Week 12)

Secondary Outcomes (1)

• Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.

  Between visit 8 and 9

Study Arms (2)

Oxycodone/Naloxone Tablets

EXPERIMENTAL

Oxycodone/Naloxone combination

Drug: Oxycodone/Naloxone

Codeine/Paracetamol Tablets

ACTIVE COMPARATOR

Codeine/Paracetamol combination

Drug: Codeine/Paracetamol

Interventions

Oxycodone/Naloxone DRUG

5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly

Oxycodone/Naloxone Tablets

Codeine/Paracetamol DRUG

15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly

Codeine/Paracetamol Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects at least 18 years or older.
• Female subjects less than one year post-menopausal must have a negative urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and reliable contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
• Subjects with a clinical diagnosis of degenerative or primary OA whose primary pain site is of the hip(s) and/or knee(s) and that require around-the-clock opioid therapy in which the diagnosis may be supported by evidence such as one of the following: MRI, CAT, arthroscopy or x-ray. The clinical imaging of OA may include one or more of the following features: joint space narrowing, degenerative changes, osteophyte formation or subchondral cysts. Subjects will identify the most painful joint (hip or knee) for documentation of OA. Pain measurement will be done at this joint only.
• Subjects with moderate to severe chronic low back pain e.g osteoarthritis, spinal stenosis, spondylolisthesis, failed back surgery, scoliosis, discogenic disorders such as herniated disc.
• Subjects who are currently receiving codeine/paracetamol combination tablets up to a maximum dose of 120 mg codeine per day or tramadol up to a maximum dose of 100 mg/day or dihydrocodeine / paracetamol tablets up to a maximum dose of 120 mg dihydrocodeine per day.
• Subjects willing and able to participate in all aspects of the core 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.
• Subjects in which the pre-study, non-opioid analgesics, and all other concomitant medications, including those medications for the treatment of depression are anticipated to remain stable throughout the treatment phase of the study.

You may not qualify if:

• Any history of hypersensitivity to oxycodone, naloxone, codeine, ibuprofen, bisacodyl or related products and ingredients.
• Any contraindication to oxycodone, naloxone, codeine, paracetamol or ibuprofen.
• Subjects with evidence of significant structural abnormalities of the GI tract (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus, hypothyroidism).
• Subjects with cancer associated pain.
• Subjects with secondary osteoarthritis (e.g. fracture, septic, acromegaly etc.).
• Active alcohol or drug abuse and/or history of opioid abuse.
• Subjects with Rheumatoid Arthritis.
• Subjects with non opioid induced constipation.
• Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the investigator's opinion, preclude entry into the study.
• Subjects who have required treatment for the diagnosis of IBS.
• Subjects receiving hypnotics or other CNS depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with opioid study medication.
• Subjects with a history of depression or other psychiatric disorder that in the opinion of the investigator is significant enough to exclude the subject from the study.
• Subjects who are currently involved in legal action regarding their pain condition or subjects in which their pain condition may be of a psychiatric nature.
• Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine).
• Subjects presently taking, or who have taken naloxone or naltrexone within 30 days of study entry (defined as the start of the Screening Period).

Sponsors & Collaborators

• Napp Pharmaceuticals Limited: lead

Study Sites (1)

Unknown Facility

Coventry, CV6 4DD, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Back Pain; Lymphoma, Follicular

Interventions

Oxycodone; Naloxone; acetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Director of Medical Affairs
• Organization: Napp Pharmaceuticals Ltd

01223 424444

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 4, 2008
• Study Start: February 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2011
• Last Updated: November 2, 2011
• Results First Posted: November 2, 2011

Record last verified: 2011-09

Locations

GB (1)