Long-term Safety of PF-00345439 (Oxycodone)

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559701
• Other study ID #: PTI-821-CM
• Secondary ID: B4501007
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2012
• Last updated: August 28, 2015
• Start date: April 2006
• Est. completion date: February 2008

Study information

• Verified date: August 2015
• Source: Pain Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 823
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• PF-00345439
5-80 mg twice-a-day for 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pain Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		12 months	Yes
Secondary	Percent change from baseline Pain Intensity Scale		baseline 1, 3, 6, 9 and 12 months	No
Secondary	Quality of Analgesia - patient reported outcome of analgesia quality using ratings of excellent, very good, good, fair, or poor.		1, 3, 6, 9 and 12 months	No
Secondary	Global Assessment of Study Medication - patient reported outcome using ratings of excellent, very good, good, fair, or poor.		1, 3, 6, 9 and 12 months	No

External Links

•   To obtain contact information for a study center near you, click here.