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| 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 |
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Egilius LH Spierings, MD, PhD | 781-431-1113 | Spierings@MedVadis.com |
| Contact: Edmund R Volkerts, PhD | 781-431-1113 | Volkerts@MedVadis.com |
| 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 | |
| Principal Investigator: | Egilius LH Spierings, MD, PhD | MedVadis Research Corporation |
More Information
| 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 |
|
opioid tolerant non-malignant pain |
|
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 |