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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930943
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : September 9, 2011
Information provided by (Responsible Party):
MedVadis Research Corporation

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
Chronic Pain Drug: Oxymorphone ER (Opana ER) Phase 4

Study Type : Interventional  (Clinical Trial)
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 2009
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Intervention Details:
    Drug: Oxymorphone ER (Opana ER)
    40 mg qd twice
    Other Name: Opana ER

Primary Outcome Measures :
  1. Rapid Visual Information Processing Test [ Time Frame: 1 and 3 hours postdose ]

Secondary Outcome Measures :
  1. Spatial Recognition Memory test [ Time Frame: 1 and 3 hours postdose ]
  2. Spatial Working Memory Test [ Time Frame: 1 and 3 hours postdose ]
  3. Verbal Recognition Memory Test [ Time Frame: 1 and 3 hours postdose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00930943

United States, Massachusetts
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States, 02481
Sponsors and Collaborators
MedVadis Research Corporation
Principal Investigator: Egilius LH Spierings, MD, PhD MedVadis Research Corporation

Responsible Party: MedVadis Research Corporation Identifier: NCT00930943     History of Changes
Other Study ID Numbers: 2009-133A
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: September 2011

Keywords provided by MedVadis Research Corporation:
opioid tolerant
chronic pain

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia