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Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

CompletedPhase 3NCT00911261
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain
Sponsor
Endo USA Inc., a Keenova Therapeutics Company
Start date
2003-08
Primary completion
2005-03
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * ≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either: 1. have an initial pain intensity score of greater than 4 on a 10-point scale using BPI Question 5, if sub-optimally responding to their current analgesic regimen, or 2. have intolerable side effects to one or more components of their current opioid-containing analgesic regimen. * Currently receive a stable (at least 2 weeks duration) analgesic regimen * If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method). * Understand written and spoken English * Have been informed of the nature of the study and provided written informed consent Additional Inclusion Criteria for Cancer Patients Only: * Have a life expectancy of at least 12 months Additional Inclusion Criteria for Neuropathic Patients Only: * Have a diagnosis of: * post-herpetic neuralgia (PHN) * diabetic neuropathy (DN) * complex regional pain syndrome (CRPS) * HIV neuropathy * idiopathic sensory neuropathy * traumatic peripheral neuropathy * central neuropathic pain condition (spinal cord injury, post-stroke pain), OR * other peripheral neuropathy (upon mutual agreement of the sponsor and investigator). Exclusion Criteria: * Have a positive pregnancy test (females only) * Have a history of or active asthma or emphysema * Have clinically significant hepatic impairment * Have a history of alcohol or substance abuse within the last 3 years * Have a history of opioid abuse within 6 months prior to study entry * Have a known allergy or significant reaction to opioids, including codeine * Have a known oxymorphone sensitivity or allergy * Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00911261