Trial Outcomes & Findings for Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning (NCT NCT00930943)

NCT ID: NCT00930943

Last Updated: 2023-05-09

Results Overview

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 \[ms\]).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 1 and 3 hours postdose
• Results posted on: 2023-05-09

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Oxymorphone 40 mg (Fed vs Fasting) n=30 Participants 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.
Age, Continuous	50.2 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants
Pain Condition Wrist pain	1 Participants n=5 Participants
Pain Condition Flank pain	1 Participants n=5 Participants
Pain Condition Chronic migraine	2 Participants n=5 Participants
Pain Condition Neck pain	4 Participants n=5 Participants
Pain Condition Low back pain	21 Participants n=5 Participants
Pain Condition Leg pain	5 Participants n=5 Participants
Pain Condition Fibromyalgia	1 Participants n=5 Participants
Pain Condition Knee pain	3 Participants n=5 Participants
Pain Condition Hip pain	4 Participants n=5 Participants
Pain Condition Shoulder pain	1 Participants n=5 Participants
Opioid use Oxycodone	16 Participants n=5 Participants
Opioid use Morphine	4 Participants n=5 Participants
Opioid use Meperidine	1 Participants n=5 Participants
Opioid use Methadone	12 Participants n=5 Participants
Opioid use Propoxyphene	1 Participants n=5 Participants
Opioid use Fentanyl	5 Participants n=5 Participants
Opioid use Codeine	1 Participants n=5 Participants
Opioid use Hydromorphone	1 Participants n=5 Participants
Opioid use Hydrocodone	1 Participants n=5 Participants
Opioid dose in morphine equivalent	206.8 mg STANDARD_DEVIATION 112.1 • n=5 Participants

PRIMARY outcome

Timeframe: 1 and 3 hours postdose

Population: Completers

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]).

Outcome measures

Measure	Oxymorphone 40 mg With High-fat Meal n=30 Participants 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.	Oxymorphone 40 mg Fasting n=30 Participants 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.
Rapid Visual Information Processing (RVP) Sensitivity [A'] 1-hour post dose	0.94 probability of detecting sequence Standard Error 0.01	0.93 probability of detecting sequence Standard Error 0.01
Rapid Visual Information Processing (RVP) Sensitivity [A'] 3-hours post dose	0.95 probability of detecting sequence Standard Error 0.01	0.96 probability of detecting sequence Standard Error 0.01

PRIMARY outcome

Timeframe: 1 and 3 hours postdose

Population: Completers

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]).

Outcome measures

Measure	Oxymorphone 40 mg With High-fat Meal n=30 Participants 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.	Oxymorphone 40 mg Fasting n=30 Participants 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.
Rapid Visual Information Processing (RVP) Response Latency 1-hour post dose	447.52 milliseconds Standard Error 17.47	455.96 milliseconds Standard Error 18.63
Rapid Visual Information Processing (RVP) Response Latency 3-hours post dose	422.33 milliseconds Standard Error 15.21	424.62 milliseconds Standard Error 18.84

SECONDARY outcome

Timeframe: 1 and 3 hours postdose

Population: completers

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]).

Outcome measures

Measure	Oxymorphone 40 mg With High-fat Meal n=30 Participants 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.	Oxymorphone 40 mg Fasting n=30 Participants 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.
Spatial Recognition Memory (SRM) Test Percentage of Correct Hits 1-hour post dose	81.67 percentage of hits Standard Error 1.78	83.17 percentage of hits Standard Error 1.37
Spatial Recognition Memory (SRM) Test Percentage of Correct Hits 3-hours post dose	80.50 percentage of hits Standard Error 1.36	81.83 percentage of hits Standard Error 1.94

SECONDARY outcome

Timeframe: 1 and 3 hours postdose

Population: completers

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]).

Outcome measures

Measure	Oxymorphone 40 mg With High-fat Meal n=30 Participants 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.	Oxymorphone 40 mg Fasting n=30 Participants 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.
Spatial Recognition Memory (SRM) Test Response Latency 3-hours post dose	1555.51 milliseconds Standard Error 60.72	1606.26 milliseconds Standard Error 61.31
Spatial Recognition Memory (SRM) Test Response Latency 1-hour post dose	1843.87 milliseconds Standard Error 98.05	1907.21 milliseconds Standard Error 104.05

SECONDARY outcome

Timeframe: 1 and 3 hours postdose

Population: completers

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).

Outcome measures

Measure	Oxymorphone 40 mg With High-fat Meal n=30 Participants 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.	Oxymorphone 40 mg Fasting n=30 Participants 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.
Spatial Working Memory (SWM) Test Total Errors 1-hour post dose	40.00 number of errors Standard Error 5.05	38.63 number of errors Standard Error 4.45
Spatial Working Memory (SWM) Test Total Errors 3-hours post dose	35.73 number of errors Standard Error 4.70	37.40 number of errors Standard Error 4.52

SECONDARY outcome

Timeframe: 1 and 3 hours postdose

Population: completers

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)

Outcome measures

Measure	Oxymorphone 40 mg With High-fat Meal n=30 Participants 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.	Oxymorphone 40 mg Fasting n=30 Participants 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.
Spatial Working Memory (SWM) Test Strategy Score 1-hour post dose	35.13 number of boxes Standard Error 1.08	35.43 number of boxes Standard Error 1.04
Spatial Working Memory (SWM) Test Strategy Score 3-hours post dose	35.50 number of boxes Standard Error 1.16	35.57 number of boxes Standard Error 1.10

Adverse Events

Oxymorphone 40 mg With High-fat Meal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxymorphone 40 mg Fasting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Egilius L.H. Spierings, M.D., Ph.D.

MedVadis Research Corporation

Phone: 781-588-5430

Email: Spierings@MedVadis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place