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Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning

CompletedPhase 4NCT00930943
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 the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.

Study details

Official title
Effect of Extended-release Oxymorphone Hydrochloride (Opana® ER), Taken Fasting Versus With Food, on Cognitive Functioning in Opioid-tolerant Subjects: a Randomized, Single-blinded, Cross-over Study
Conditions
Sponsor
MedVadis Research Corporation
Start date
2009-05
Primary completion
2009-11
Sex
All
Age range
from 18 Years to 65 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Man or woman, 18-65 years of age, inclusive 2. Able to provide informed consent and comply with all study procedures 3. Women of childbearing potential with a negative urine pregnancy test at screening and on adequate contraception 4. Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone, OxyContin®, MS (Morphine Sulfate) Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER) 5. Opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch 6. Dose of opioid treatment stable for at least 1 week prior to screening and expected to be stable from screening through end of second testing 7. Weight at screening 100-300 pounds, inclusive Exclusion Criteria: 1. Pregnant or breastfeeding 2. Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of study medication (delayed gastric emptying, partial or complete gastrectomy) 3. Alcohol or substance abuse within 2 years of screening 4. Consumption of alcohol within 24 hours of a screening or testing visit 5. Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a screening or testing visit 6. Impaired kidney or liver function (transaminase levels more than 3 times elevated; estimated creatinine clearance less than 50 mL/min) 7. Epworth sleepiness scale (ESS) score 16 or higher at screening 8. Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness 9. Any clinically significant illness that would interfere with study participation or put the subject at risk 10. Exposure to investigational medication within 30 days of screening

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00930943