Long-term Safety of PF-00345439 (Oxycodone)

This study has been completed.
Information provided by (Responsible Party):
Pain Therapeutics
ClinicalTrials.gov Identifier:
First received: March 13, 2012
Last updated: August 28, 2015
Last verified: August 2015

March 13, 2012
August 28, 2015
April 2006
February 2008   (final data collection date for primary outcome measure)
Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01559701 on ClinicalTrials.gov Archive Site
  • Percent change from baseline Pain Intensity Scale [ Time Frame: baseline 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
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

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

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.

Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug: PF-00345439
5-80 mg twice-a-day for 12 months
Other Name: PTI-821, Remoxy
Experimental: PF-00345439 (oxycodone)
PF-00345439 (oxycodone)
Intervention: Drug: PF-00345439
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
18 Years to 75 Years
Contact information is only displayed when the study is recruiting subjects
Not Provided
PTI-821-CM, B4501007
Pain Therapeutics
Pain Therapeutics
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pain Therapeutics
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP