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Long-term Safety of PF-00345439 (Oxycodone)

This study has been completed.
Sponsor:
Collaborator:
Pain Therapeutics, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01559701
First received: March 13, 2012
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559701

Sponsors and Collaborators
Pfizer
Pain Therapeutics, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01559701     History of Changes
Other Study ID Numbers: PTI-821-CM, B4501007
Study First Received: March 13, 2012
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Safety
PF-00345439
Remoxy
PTI-821

Additional relevant MeSH terms:
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on June 17, 2013