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

Information source: MedVadis Research Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: Oxymorphone ER (Opana ER) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: MedVadis Research Corporation

Official(s) and/or principal investigator(s):
Egilius LH Spierings, MD, PhD, Principal Investigator, Affiliation: MedVadis Research Corporation

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 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rapid Visual Information Processing Test

Secondary outcome:

Spatial Recognition Memory test

Spatial Working Memory Test

Verbal Recognition Memory Test

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 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

Locations and Contacts

MedVadis Research Corporation, Wellesley Hills, Massachusetts 02481, United States
Additional Information

Starting date: May 2009
Last updated: September 8, 2011

Page last updated: August 23, 2015

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