Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Oxymorphone 40 mg ER affects cognitive performance similarly within 3 hours post dose, whether given on an empty stomach or after a high-fat meal, suggesting that the altered pharmacokinetics, fed versus fasting and as described above, is not relevant for the medication's impact on cognition. Hence, the direction for oxymorphone ER to be dosed at least 1 hour before or 2 hours after eating, at least from a cognitive perspective, may be without merit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxymorphone ER 40 mg fed | Experimental | Participants received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal |
|
| Oxymorphone ER 40 mg fasting | Experimental | Participants received 40 mg oxymorphone ER after fasting for 8-12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymorphone ER | Drug | 40 mg qd twice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rapid Visual Information Processing (RVP) Sensitivity [A'] | RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity [A']) and the speed at which the sequence is registered (response latency [ms]). | 1 and 3 hours postdose |
| Rapid Visual Information Processing (RVP) Response Latency | RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity [A']) and the speed at which the sequence is registered (response latency [ms]). | 1 and 3 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Spatial Recognition Memory (SRM) Test Percentage of Correct Hits | SRM tests visual spatial recognition memory in a two-choice forced discrimination paradigm. The subject is presented with a white square, which appears in sequence at five different locations on the screen. In the recognition phase, the subject sees a series of five pairs of squares, one of which is in a place previously seen in the presentation phase. The other square is in a location not seen in the presentation phase. Locations are tested in the reverse of the presentation order. The two main outcome measures are the percentage of correct trials (correct hits [%]) and the speed of the subject's response (response latency [ms]). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Egilius LH Spierings, MD, PhD | MedVadis Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedVadis Research Corporation | Wellesley Hills | Massachusetts | 02481 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24330343 | Result | Spierings EL, Volkerts ER, Heitland I, Thomson H. A randomized, rater-blinded, crossover study of the effects of oxymorphone extended release, fed versus fasting, on cognitive performance as tested with CANTAB in opioid-tolerant subjects. Pain Med. 2014 Feb;15(2):264-71. doi: 10.1111/pme.12307. Epub 2013 Dec 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Oxymorphone 40 mg (Fed vs Fasting) | After completion of the screening process and assuring eligibility in terms of inclusion/exclusion criteria, the subjects were randomized to determine at which testing visit a high-fat meal was to be consumed. (Note: randomization data are not available because old data records have been destroyed) They were instructed not to eat or drink, except for water, after midnight on the night before testing, not to consume alcohol within 24 hours of testing and xanthine-containing beverages (coffee, tea, coca cola, energy drinks, etc.) on the morning of the testing. Subjects who were taking an oral opioid were instructed not to take their morning dose on the days of testing, and those who used the transdermal fentanyl patch were instructed not to change the patch the night before. Each testing visit consisted of an assessment of adverse health and concomitant-medication changes and also a blood alcohol draw, followed by a high-fat breakfast, if applicable. Under supervision, the subjects took the study medication, a single dose of 40 mg oxymorphone ER, with water. Cognitive performance was assessed 1 hour and 3 hours post-dose using three Cambridge Neuropsychological Test Automated Battery (CANTAB) tests. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oxymorphone 40 mg (Fed vs Fasting) | After completion of the screening process and assuring eligibility in terms of inclusion/exclusion criteria, the subjects were randomized to determine at which testing visit a high-fat meal was to be consumed. (Note: randomization data are not available) They were instructed not to eat or drink, except for water, after midnight on the night before testing, not to consume alcohol within 24 hours of testing and xanthine-containing beverages (coffee, tea, coca cola, energy drinks, etc.) on the morning of the testing. Subjects who were taking an oral opioid were instructed not to take their morning dose on the days of testing, and those who used the transdermal fentanyl patch were instructed not to change the patch the night before. Each testing visit consisted of an assessment of adverse health and concomitant-medication changes and also a blood alcohol draw, followed by a high-fat breakfast, if applicable. Under supervision, the subjects took the study medication, a single dose of 40 mg oxymorphone ER, with water. Cognitive performance was assessed 1 hour and 3 hours post-dose using three Cambridge Neuropsychological Test Automated Battery (CANTAB) tests. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rapid Visual Information Processing (RVP) Sensitivity [A'] | RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity [A']) and the speed at which the sequence is registered (response latency [ms]). | Completers | Posted | Mean | Standard Error | probability of detecting sequence | 1 and 3 hours postdose |
|
1 month
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxymorphone 40 mg With High-fat Meal | Participants were instructed not to eat or drink, except for water, after midnight on the night before testing, not to consume alcohol within 24 hours of testing and xanthine-containing beverages (coffee, tea, coca cola, energy drinks, etc.) on the morning of the testing. Subjects who were taking an oral opioid were instructed not to take their morning dose on the days of testing, and those who used the transdermal fentanyl patch were instructed not to change the patch the night before. Each testing visit consisted of an assessment of adverse health and concomitant-medication changes and also a blood alcohol draw, followed by a high-fat breakfast. Under supervision, the subjects took the study medication, a single dose of 40 mg oxymorphone ER, with water. Cognitive performance was assessed 1 hour and 3 hours post-dose using three Cambridge Neuropsychological Test Automated Battery (CANTAB) tests. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Egilius L.H. Spierings, M.D., Ph.D. | MedVadis Research Corporation | 781-588-5430 | Spierings@MedVadis.com |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 and 3 hours postdose |
| Spatial Recognition Memory (SRM) Test Response Latency | SRM tests visual spatial recognition memory in a two-choice forced discrimination paradigm. The subject is presented with a white square, which appears in sequence at five different locations on the screen. In the recognition phase, the subject sees a series of five pairs of squares, one of which is in a place previously seen in the presentation phase. The other square is in a location not seen in the presentation phase. Locations are tested in the reverse of the presentation order. The two main outcome measures are the percentage of correct trials (correct hits [%]) and the speed of the subject's response (response latency [ms]). | 1 and 3 hours postdose |
| Spatial Working Memory (SWM) Test Total Errors | SWM is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. It is a self-ordered task, which also assesses heuristic strategy. The test is a sensitive measure of executive function. It begins with a number of colored squares (boxes) being shown on the screen. By touching the boxes and using a process of elimination, the subject finds blue tokens in a number of boxes and uses them to fill up an empty column on the screen. The number of boxes is gradually increased, until it is necessary to search a total of eight boxes. The color and position of the boxes are changed from trial to trial to discourage the use of stereotyped search strategies. The two main outcome measures are errors (touching boxes that have been found to be empty and revisiting boxes that have already been found to contain a token - total errors) and a measure of strategy (strategy score). | 1 and 3 hours postdose |
| Spatial Working Memory (SWM) Test Strategy Score | SWM is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. The test is a sensitive measure of executive function. It begins with a number of colored squares (boxes) being shown on the screen. By touching the boxes and using a process of elimination, the subject finds blue tokens in a number of boxes and uses them to fill up an empty column on the screen. The number of boxes is gradually increased, until it is necessary to search a total of eight boxes. The color and position of the boxes are changed from trial to trial to discourage the use of stereotyped search strategies. The two main outcome measures are errors (touching boxes that have been found to be empty and revisiting boxes that have already been found to contain a token - total errors) and a measure of strategy (For assessed problems with six boxes or more, the number of distinct boxes used by the subject to begin a new search for a token) | 1 and 3 hours postdose |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pain Condition | Number of Participants treated for the indicated condition. Participants may report more than one condition | Count of Participants | Participants |
|
| Opioid use | Opioid used as treatment for chronic pain condition. Participants may take more than one opioid. | Count of Participants | Participants |
|
| Opioid dose in morphine equivalent | Mean | Standard Deviation | mg |
|
| OG001 | Oxymorphone 40 mg Fasting | Participants were instructed not to eat or drink, except for water, after midnight on the night before testing, not to consume alcohol within 24 hours of testing and xanthine-containing beverages (coffee, tea, coca cola, energy drinks, etc.) on the morning of the testing. Subjects who were taking an oral opioid were instructed not to take their morning dose on the days of testing, and those who used the transdermal fentanyl patch were instructed not to change the patch the night before. Each testing visit consisted of an assessment of adverse health and concomitant-medication changes and also a blood alcohol draw. Under supervision, the subjects took the study medication, a single dose of 40 mg oxymorphone ER, with water. Cognitive performance was assessed 1 hour and 3 hours post-dose using three Cambridge Neuropsychological Test Automated Battery (CANTAB) tests. |
|
|
|
| Primary | Rapid Visual Information Processing (RVP) Response Latency | RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity [A']) and the speed at which the sequence is registered (response latency [ms]). | Completers | Posted | Mean | Standard Error | milliseconds | 1 and 3 hours postdose |
|
|
|
|
| Secondary | Spatial Recognition Memory (SRM) Test Percentage of Correct Hits | SRM tests visual spatial recognition memory in a two-choice forced discrimination paradigm. The subject is presented with a white square, which appears in sequence at five different locations on the screen. In the recognition phase, the subject sees a series of five pairs of squares, one of which is in a place previously seen in the presentation phase. The other square is in a location not seen in the presentation phase. Locations are tested in the reverse of the presentation order. The two main outcome measures are the percentage of correct trials (correct hits [%]) and the speed of the subject's response (response latency [ms]). | completers | Posted | Mean | Standard Error | percentage of hits | 1 and 3 hours postdose |
|
|
|
|
| Secondary | Spatial Recognition Memory (SRM) Test Response Latency | SRM tests visual spatial recognition memory in a two-choice forced discrimination paradigm. The subject is presented with a white square, which appears in sequence at five different locations on the screen. In the recognition phase, the subject sees a series of five pairs of squares, one of which is in a place previously seen in the presentation phase. The other square is in a location not seen in the presentation phase. Locations are tested in the reverse of the presentation order. The two main outcome measures are the percentage of correct trials (correct hits [%]) and the speed of the subject's response (response latency [ms]). | completers | Posted | Mean | Standard Error | milliseconds | 1 and 3 hours postdose |
|
|
|
|
| Secondary | Spatial Working Memory (SWM) Test Total Errors | SWM is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. It is a self-ordered task, which also assesses heuristic strategy. The test is a sensitive measure of executive function. It begins with a number of colored squares (boxes) being shown on the screen. By touching the boxes and using a process of elimination, the subject finds blue tokens in a number of boxes and uses them to fill up an empty column on the screen. The number of boxes is gradually increased, until it is necessary to search a total of eight boxes. The color and position of the boxes are changed from trial to trial to discourage the use of stereotyped search strategies. The two main outcome measures are errors (touching boxes that have been found to be empty and revisiting boxes that have already been found to contain a token - total errors) and a measure of strategy (strategy score). | completers | Posted | Mean | Standard Error | number of errors | 1 and 3 hours postdose |
|
|
|
|
| Secondary | Spatial Working Memory (SWM) Test Strategy Score | SWM is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. The test is a sensitive measure of executive function. It begins with a number of colored squares (boxes) being shown on the screen. By touching the boxes and using a process of elimination, the subject finds blue tokens in a number of boxes and uses them to fill up an empty column on the screen. The number of boxes is gradually increased, until it is necessary to search a total of eight boxes. The color and position of the boxes are changed from trial to trial to discourage the use of stereotyped search strategies. The two main outcome measures are errors (touching boxes that have been found to be empty and revisiting boxes that have already been found to contain a token - total errors) and a measure of strategy (For assessed problems with six boxes or more, the number of distinct boxes used by the subject to begin a new search for a token) | completers | Posted | Mean | Standard Error | number of boxes | 1 and 3 hours postdose |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Oxymorphone 40 mg Fasting | Participants were instructed not to eat or drink, except for water, after midnight on the night before testing, not to consume alcohol within 24 hours of testing and xanthine-containing beverages (coffee, tea, coca cola, energy drinks, etc.) on the morning of the testing. Subjects who were taking an oral opioid were instructed not to take their morning dose on the days of testing, and those who used the transdermal fentanyl patch were instructed not to change the patch the night before. Each testing visit consisted of an assessment of adverse health and concomitant-medication changes and also a blood alcohol draw. Under supervision, the subjects took the study medication, a single dose of 40 mg oxymorphone ER, with water. Cognitive performance was assessed 1 hour and 3 hours post-dose using three Cambridge Neuropsychological Test Automated Battery (CANTAB) tests. | 0 | 30 | 0 | 30 | 0 | 30 |
Not provided
Not provided
Not provided
| >0.05 |
repeated-measure ANOVA testing "food" and "food x time post dose" effect for Rapid Visual Information Processing (RVP): response latency |
| Superiority |
| >0.05 |
repeated-measure ANOVA testing "food" and "food x time-post-dose" effect for SRM response latency |
| Superiority |