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Long-term Safety of PF-00345439 (Oxycodone)

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. Identifier: NCT01559701
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : September 11, 2015
Information provided by (Responsible Party):
Pain Therapeutics

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

Condition or disease Intervention/treatment Phase
Pain Drug: PF-00345439 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 823 participants
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
Study Start Date : April 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PF-00345439 (oxycodone)
PF-00345439 (oxycodone)
Drug: PF-00345439
5-80 mg twice-a-day for 12 months
Other Name: PTI-821, Remoxy

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

Secondary Outcome Measures :
  1. Percent change from baseline Pain Intensity Scale [ Time Frame: baseline 1, 3, 6, 9 and 12 months ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01559701

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

Additional Information:
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Responsible Party: Pain Therapeutics Identifier: NCT01559701     History of Changes
Other Study ID Numbers: PTI-821-CM
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: August 2015

Keywords provided by Pain Therapeutics:

Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents