NCT00911261

Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.

Detailed description

The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.

Conditions

• Chronic Pain
• Neuropathic Pain
• Cancer

Interventions

Type	Name	Description
DRUG	Oxymorphone Extended Release	* Study Medication: Oxymorphone ER 5 mg, 10 mg, 20 mg, and 40 mg tablets * Rescue Medication: Oxymorphone IR 5 mg and 10 mg tablets * Treatment will consist of up to 12 months of dosing with Oxymorphone ER.

Timeline

• Start date: 2003-08-01
• Primary completion: 2005-03-01
• Completion: 2005-05-01
• First posted: 2009-06-01
• Last updated: 2010-02-15