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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedVadis Research Corporation
• Treatments: Oxymorphone

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