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| Sponsor: | MedVadis Research Corporation |
|---|---|
| Information provided by (Responsible Party): | 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 Pain |
Drug: Oxymorphone ER (Opana ER) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (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 |
| Enrollment: | 30 |
| Study Start Date: | May 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (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| United States, Massachusetts | |
| MedVadis Research Corporation | |
| Wellesley Hills, Massachusetts, United States, 02481 | |
| Principal Investigator: | Egilius LH Spierings, MD, PhD | MedVadis Research Corporation |
More Information
| Responsible Party: | MedVadis Research Corporation |
| ClinicalTrials.gov Identifier: | NCT00930943 History of Changes |
| Other Study ID Numbers: | 2009-133A |
| Study First Received: | June 29, 2009 |
| Last Updated: | September 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
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opioid tolerant chronic pain |
|
Oxymorphone Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics, Opioid |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics |