Phase 4
N=30
Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00930943 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Rapid Visual Information Processing (RVP) Sensitivity [A'] — 0.94; 0.93; 0.95; 0.96 probability of detecting sequence — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxymorphone ER (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedVadis Research Corporation
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rapid Visual Information Processing (RVP) Sensitivity [A'] |
0.94; 0.93; 0.95; 0.96 | <0.001 sig |
| PRIMARY Rapid Visual Information Processing (RVP) Response Latency |
447.52; 455.96; 422.33; 424.62 | <0.001 sig |
| SECONDARY Spatial Recognition Memory (SRM) Test Percentage of Correct Hits |
81.67; 83.17; 80.50; 81.83 | >0.05 |
| SECONDARY Spatial Recognition Memory (SRM) Test Response Latency |
1843.87; 1907.21; 1555.51; 1606.26 | <0.001 sig |
| SECONDARY Spatial Working Memory (SWM) Test Total Errors |
40.00; 38.63; 35.73; 37.40 | >0.05 |
| SECONDARY Spatial Working Memory (SWM) Test Strategy Score |
35.13; 35.43; 35.50; 35.57 | >0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00930943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.