An Open-Label Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.

Endo Pharmaceuticals0 sites129 target enrollmentJune 2003

ConditionsPain Chronic Disease

InterventionsOxymorphone extended release

DrugsOxymorphone extended release

Overview

Phase: Phase 3
Intervention: Oxymorphone extended release
Conditions: Pain
Sponsor: Endo Pharmaceuticals
Enrollment: 129
Primary Endpoint: Tolerability.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.

Detailed Description

The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

March 2004

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Endo Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Currently receive a stable non-opioid analgesic regimen
•Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe
•If female, must be practicing abstinence or using a medically acceptable form of contraception
•Understand written and spoken English
•Have been informed of the nature of the study and provided written informed consent.

Exclusion Criteria

•Positive pregnancy test (females only)
•History of or active asthma or emphysema
•Clinically significant hepatic impairment
•Received any of the following medications within 48 hours prior to dosing:
•Dextromethorphan-containing medications (over-the-counter \[OTC\] cough and cold preparations, such as Vicks Formula 44)
•St. John's Wort \>1000 mg/day
•Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing
•Are not stabilized on the following medications for at least 4 weeks prior to dosing:
•Tricyclic antidepressant drugs
•Serotonin reuptake inhibitors

Arms & Interventions

Single Arm

Intervention: Oxymorphone extended release

Outcomes

Primary Outcomes

Tolerability.

Time Frame: Entire study duration, including follow-up period.

Secondary Outcomes

Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period(Week 1-4, Month 1-6)
Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire(Week 1-4, Month 1-6)
Average daily dose of oxymorphone ER(Entire study duration)
Rescue medication.(Entire study duration)
Total daily dose of oxymorphone ER and rescue medication(Entire study duration)
Time to stabilization. Patient/investigator global assessments(Month 6)
Treatment satisfaction(Month 6)