Long-term Safety of PF-00345439 (Oxycodone)

August 28, 2015 updated by: Pain Therapeutics

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

823

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PF-00345439 (oxycodone)
Drug: PF-00345439
5-80 mg twice-a-day for 12 months
Other Names:
  • PTI-821, Remoxy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline Pain Intensity Scale
Time Frame: baseline 1, 3, 6, 9 and 12 months
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
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
1, 3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pain Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

August 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PTI-821-CM
  • B4501007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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