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Long-term Safety of PF-00345439 (Oxycodone)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559701
First Posted: March 21, 2012
Last Update Posted: September 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pain Therapeutics
March 13, 2012
March 21, 2012
September 11, 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 ]
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 ]
  • 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 ]
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
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.
 
Completed
823
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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01559701
PTI-821-CM
B4501007
No
Not Provided
Not Provided
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