Status:
COMPLETED
Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
Lead Sponsor:
MedVadis Research Corporation
Conditions:
Chronic Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 functionin...
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 ver...
Eligibility Criteria
Inclusion
- Man or woman, 18-65 years of age, inclusive
- Able to provide informed consent and comply with all study procedures
- Women of childbearing potential with a negative urine pregnancy test at screening and on adequate contraception
- Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone, OxyContin®, MS (Morphine Sulfate) Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER)
- 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
- 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
- Weight at screening 100-300 pounds, inclusive
Exclusion
- Pregnant or breastfeeding
- Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of study medication (delayed gastric emptying, partial or complete gastrectomy)
- Alcohol or substance abuse within 2 years of screening
- Consumption of alcohol within 24 hours of a screening or testing visit
- Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a screening or testing visit
- Impaired kidney or liver function (transaminase levels more than 3 times elevated; estimated creatinine clearance less than 50 mL/min)
- Epworth sleepiness scale (ESS) score 16 or higher at screening
- Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness
- Any clinically significant illness that would interfere with study participation or put the subject at risk
- Exposure to investigational medication within 30 days of screening
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00930943
Start Date
May 1 2009
End Date
November 1 2009
Last Update
May 9 2023
Active Locations (1)
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1
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States, 02481