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

Phase 4 Completed 30 enrolled MedVadis Research Corporation

RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start: 2009-05
Primary completion: 2009-11
Completion: 2009-11

Outcome

Missed primary endpoint

registry analysis (superiority test); Oxymorphone 40 mg With High-fat Meal vs Oxymorphone 40 mg Fasting; p >0.05; ANOVA; note: repeated-measure ANOVA testing food effect for Rapid Visual Information Processing (RVP): sensitivity (A') NCT00930943 ↗

registry analysis (superiority test); Oxymorphone 40 mg With High-fat Meal vs Oxymorphone 40 mg Fasting; p >0.05; ANOVA; note: repeated-measure ANOVA testing "food" and "food x time post dose" effect for Rapid Visual Information Processing (RVP): response latency NCT00930943 ↗

Publications

Results Spierings EL, Volkerts ER, Heitland I, Thomson H. A randomized, rater-blinded, crossover study of the effects of oxymorphone extended release, fed versus fasting, on cognitive performance as tested with CANTAB in opioid-tolerant subjects. Pain Med. 2014 Feb;15(2):264-71. doi: 10.1111/pme.12307. Epub 2013 Dec 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxymorphone	Small molecule	40 mg	Oral