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Long-term Safety of PF-00345439 (Oxycodone)

This study has been completed.
Information provided by (Responsible Party):
Pain Therapeutics Identifier:
First received: March 13, 2012
Last updated: August 28, 2015
Last verified: August 2015
Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low Back Pain Or Osteoarthritis

Condition Intervention Phase
Pain Drug: PF-00345439 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Pain Therapeutics:

Primary Outcome Measures:
  • Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Percent change from baseline Pain Intensity Scale [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 1, 3, 6, 9 and 12 months ]

Enrollment: 823
Study Start Date: April 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00345439 (oxycodone)
PF-00345439 (oxycodone)
Drug: PF-00345439
5-80 mg twice-a-day for 12 months
Other Name: PTI-821, Remoxy

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01559701

Sponsors and Collaborators
Pain Therapeutics
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pain Therapeutics Identifier: NCT01559701     History of Changes
Other Study ID Numbers: PTI-821-CM
Study First Received: March 13, 2012
Last Updated: August 28, 2015

Keywords provided by Pain Therapeutics:

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on August 22, 2017