Long-term Safety of PF-00345439 (Oxycodone)

Study Overview
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Brief Summary
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Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low Back Pain Or Osteoarthritis

Detailed Description
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This study will evaluate: (a) the long-term safety of PTI-821 during a 12-month period; and (b) the long-term efficacy of PTI-821 by assessing pain intensity (PI), the quality of analgesia, and the global assessment of study medication.

Official Title
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A Long-Term, Open-Label, Safety Study Of PTI-821 In Patients With Moderate To Severe Chronic Low Back Pain Or With Moderate To Severe Chronic Pain Due To Osteoarthritis Of The Hip Or Knee

Conditions
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Pain

Intervention / Treatment
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* Drug: PF-00345439


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females who are ≥ 18 and ≤ 75 years of age with moderate to severe pain in one or more hip or knee joint(s) caused by osteoarthritis for at least three months prior to the Baseline Visit or persistent moderate to severe low back pain for at least six months while regularly taking one or more of the following types of oral analgesic medication(s) prior to the Baseline Visit. Patient agrees to refrain from taking any opioid medications other than study drug during the study period. Patients must agree to report all non-opioid analgesic medications taken. Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or IUD). If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained at the Baseline Visit. Exclusion Criteria: Patient has a positive urine drug screen at the Baseline Visit. Patient currently is on an opioid regimen with a daily opioid dose equivalent of oxycodone > 160 mg. Patient has major surgery planned during the proposed study period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-00345439 (oxycodone)<br>PF-00345439 (oxycodone) | Drug: PF-00345439<br>* 5-80 mg twice-a-day for 12 months<br>* Other names: PTI-821, Remoxy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline Pain Intensity Scale |  | baseline 1, 3, 6, 9 and 12 months | 
| Quality of Analgesia - patient reported outcome of analgesia quality using ratings of excellent, very good, good, fair, or poor. |  | 1, 3, 6, 9 and 12 months | 
| Global Assessment of Study Medication - patient reported outcome using ratings of excellent, very good, good, fair, or poor. |  | 1, 3, 6, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, PF-00345439, Remoxy, PTI-821