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Effect of Extended-Release Oxymorphone Taking With or Without Food on Cognitive Functioning
This study is currently recruiting participants.
Verified by MedVadis Research Corporation, June 2009
First Received: June 29, 2009   Last Updated: June 30, 2009   History of Changes
Sponsor: MedVadis Research Corporation
Information provided by: MedVadis Research Corporation
ClinicalTrials.gov Identifier: NCT00930943
  Purpose

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 Intervention Phase
Chronic Non-Malignant Pain
Drug: Oxymorphone ER (Opana ER)
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study
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

Resource links provided by NLM:


Further study details as provided by MedVadis Research Corporation:

Primary Outcome Measures:
  • Rapid Visual Information Processing Test [ Time Frame: 1 and 3 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spatial Recognition Memory test [ Time Frame: 1 and 3 hours postdose ] [ Designated as safety issue: No ]
  • Spatial Working Memory Test [ Time Frame: 1 and 3 hours postdose ] [ Designated as safety issue: No ]
  • Verbal Recognition Memory Test [ Time Frame: 1 and 3 hours postdose ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oxymorphone ER (Opana ER)
    40 mg qd twice
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930943

Contacts
Contact: Egilius LH Spierings, MD, PhD 781-431-1113 Spierings@MedVadis.com
Contact: Edmund R Volkerts, PhD 781-431-1113 Volkerts@MedVadis.com

Locations
United States, Massachusetts
MedVadis Research Corporation Recruiting
Wellesley Hills, Massachusetts, United States, 02481
Principal Investigator: Egilius LH Spierings, MD, PhD            
Sub-Investigator: Edmund R Volkerts, PhD            
Sponsors and Collaborators
MedVadis Research Corporation
Investigators
Principal Investigator: Egilius LH Spierings, MD, PhD MedVadis Research Corporation
  More Information

No publications provided

Responsible Party: MedVadis Research Corporation ( Egilius L.H. Spierings, M.D., Ph.D. )
Study ID Numbers: 2009-133A
Study First Received: June 29, 2009
Last Updated: June 30, 2009
ClinicalTrials.gov Identifier: NCT00930943     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by MedVadis Research Corporation:
opioid tolerant
non-malignant pain

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid
Oxymorphone

ClinicalTrials.gov processed this record on February 09, 2010