NCT00930943

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: MedVadis Research Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Oxymorphone ER	40 mg qd twice

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-07-02
• Last updated: 2023-05-09
• Results posted: 2023-05-09

Locations

1 site across 1 country: United States