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

Chronic Pain Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

Oxymorphone 40 mg ER affects cognitive performance similarly within 3 hours post dose, whether given on an empty stomach or after a high-fat meal, suggesting that the altered pharmacokinetics, fed versus fasting and as described above, is not relevant for the medication's impact on cognition. Hence, the direction for oxymorphone ER to be dosed at least 1 hour before or 2 hours after eating, at least from a cognitive perspective, may be without merit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00930943
Study type Interventional
Source MedVadis Research Corporation
Contact
Status Completed
Phase Phase 4
Start date May 2009
Completion date November 2009
View Details
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