Long-term Safety of PF-00345439 (Oxycodone)

Pain Therapeutics

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: PF-00345439

Study type

Interventional

Funder types

Industry

Identifiers

NCT01559701

B4501007

PTI-821-CM

Details and patient eligibility

About

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

Full 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.

Enrollment

823 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.