Long-term Safety of PF-00345439 (Oxycodone)
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
2 other identifiers
interventional
823
0 countries
N/A
Brief Summary
Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low Back Pain Or Osteoarthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Apr 2006
Typical duration for phase_3 pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 21, 2012
CompletedSeptember 11, 2015
August 1, 2015
1.8 years
March 13, 2012
August 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
12 months
Secondary Outcomes (3)
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
Study Arms (1)
PF-00345439 (oxycodone)
EXPERIMENTALPF-00345439 (oxycodone)
Interventions
5-80 mg twice-a-day for 12 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2012
First Posted
March 21, 2012
Study Start
April 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
September 11, 2015
Record last verified: 2015-08