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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 (OXN4502)
This study is not yet open for participant recruitment.
Verified by Napp Pharmaceuticals Limited, November 2008
Sponsored by: Napp Pharmaceuticals Limited
Information provided by: Napp Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00784810
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Back Pain
Drug: Oxycodone/Naloxone
Phase IV

MedlinePlus related topics: Back Pain Osteoarthritis
Drug Information available for: Naloxone Naloxone hydrochloride Oxycodone Oxycodone hydrochloride Acetaminophen Codeine Codeine phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double-Blind, Double-Dummy, Parallel Group, Randomised Study to Compare the Efficacy and Tolerability of Oxycodone/Naloxone Prolonged Release (OXN PR) & Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis

Further study details as provided by Napp Pharmaceuticals Limited:

Primary Outcome Measures:
  • Average daily pain score Box Scale - 11 (BS-11) recorded each day in the diary.

Secondary Outcome Measures:
  • Assessment of pain & locomotor function by WOMAC VA3.1. BPI-SF. Rescue medication use. MOS Sleep scale. BFI assessed for the last 7 days. PAC-SYM(b); An adaptation of PAC-SYM which includes the first 12 questions of the validated PAC-SYM & an additional

Estimated Enrollment: 244
Study Start Date: January 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Oxycodone/Naloxone
Drug: Oxycodone/Naloxone
Treatment of moderate to severe chronic low back pain or pain due to osteoarthritis
2: Active Comparator
Codeine/Paracetamol
Drug: Oxycodone/Naloxone
Treatment of moderate to severe chronic low back pain or pain due to osteoarthritis

Detailed Description:

This is a randomised, double-blind, double-dummy, parallel group, 12-week study to assess the efficacy and tolerability of oxycodone/naloxone compared to codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or moderate to severe pain due to OA of the hip and /or knee.

The screening period will be 3 - 7 days duration. If a subject meets all the screening criteria they may enter the Run-in Period.

During the screening period subjects will continue to take their pre-study pain medication.

The run-in period will be 7 - 14 days duration. During the run-in period subjects will continue to take their pre-study pain medication.

Visit 3 will occur at the end of the Run-in Period (7-14 days after Visit 2). To qualify for entry into the treatment period of the study, subjects must have uncontrolled pain as shown by average daily pain scores of >5 on 4 of the last 7 days of the run in period.

Eligible subjects will be randomised to either oxycodone/naloxone or codeine/paracetamol tablets. Subjects will receive double-blind study medication for up to 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects at least 18 years or older.
  2. 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 (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner.
  3. 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: magnetic resonance imaging (MRI), computerised axial tomography (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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.

Exclusion Criteria:

  1. Any history of hypersensitivity to oxycodone, naloxone, codeine, ibuprofen, bisacodyl or related products and ingredients.
  2. Any contraindication to oxycodone, naloxone, codeine, paracetamol or ibuprofen.
  3. Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus, hypothyroidism).
  4. Subjects with cancer associated pain.
  5. Subjects with secondary osteoarthritis (e.g. fracture, septic, acromegaly etc.).
  6. Active alcohol or drug abuse and/or history of opioid abuse.
  7. Subjects with Rheumatoid Arthritis (RA).
  8. Subjects with non opioid induced constipation.
  9. 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.
  10. Subjects with evidence of impaired liver/kidney function upon entry into the study defined as aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels >3 times the upper limit of normal; gamma glutamyl transpeptidase (GGT or GGTP) ≥5 times the upper limit of normal; total bilirubin level outside of the reference range; and/or creatinine level outside of the reference range or > 2 mg/dl, or in the investigator's opinion, liver and/or kidney impairment to the extent that the subject should not participate in this study.
  11. Subjects who have required treatment for the diagnosis of irritable bowel syndrome (IBS).
  12. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with opioid study medication.
  13. 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.
  14. 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.
  15. Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine).
  16. Subjects presently taking, or who have taken naloxone or naltrexone within 30 days of study entry (defined as the start of the Screening Period).
  17. Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the12-week treatment period that may affect GI motility or pain levels.
  18. Subjects who have received a new chemical entity or an experimental drug within 30 days of study entry (define as the start of the Screening Period).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784810

Contacts
Contact: Jill Kiteley info@contact-clinical-trials.com
Contact: Margaret Wilson info@contact-clinical-trials.com

Sponsors and Collaborators
Napp Pharmaceuticals Limited
  More Information

Study ID Numbers: 2008-002426-10
Study First Received: November 3, 2008
Last Updated: November 3, 2008
ClinicalTrials.gov Identifier: NCT00784810  
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Napp Pharmaceuticals Limited:
Efficacy
tolerability
moderate
severe
oxycodone
naloxone
codeine
paracetamol
chronic
low back
pain
osteoarthritis
Moderate to severe chronic low back pain or pain due to osteoarthritis.

Study placed in the following topic categories:
Osteoarthritis
Joint Diseases
Oxycodone
Low Back Pain
Pain
Rheumatic Diseases
Back Pain
Codeine
Naloxone
Naphazoline
Oxymetazoline
Signs and Symptoms
Musculoskeletal Diseases
Guaifenesin
Phenylephrine
Arthritis
Neurologic Manifestations
Phenylpropanolamine
Acetaminophen

Additional relevant MeSH terms:
Respiratory System Agents
Narcotic Antagonists
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009