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

Sponsor
MedVadis Research Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00930943
Collaborator
(none)
30
Enrollment
1
Location
6
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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 functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxymorphone ER (Opana ER)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2009
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Rapid Visual Information Processing Test [1 and 3 hours postdose]

Secondary Outcome Measures

  1. Spatial Recognition Memory test [1 and 3 hours postdose]

  2. Spatial Working Memory Test [1 and 3 hours postdose]

  3. Verbal Recognition Memory Test [1 and 3 hours postdose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MedVadis Research Corporation Wellesley Hills Massachusetts United States 02481

Sponsors and Collaborators

  • MedVadis Research Corporation

Investigators

  • Principal Investigator: Egilius LH Spierings, MD, PhD, MedVadis Research Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MedVadis Research Corporation
ClinicalTrials.gov Identifier:
NCT00930943
Other Study ID Numbers:
  • 2009-133A
First Posted:
Jul 2, 2009
Last Update Posted:
Sep 9, 2011
Last Verified:
Sep 1, 2011
Keywords provided by MedVadis Research Corporation
opioid tolerant
chronic pain
Additional relevant MeSH terms:
Chronic Pain
Oxymorphone

Study Results

No Results Posted as of Sep 9, 2011