Trial · NCT00930943

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

NCT00930943, Phase 4, Completed, MedVadis Research Corporation; results first posted 2023-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning. Trials, record NCT00930943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00930943

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
NCT number: NCT00930943
Status: Completed
Phases: Phase 4
Enrollment: 30 participants, actual
Lead sponsor: MedVadis Research Corporation
Conditions: Chronic Pain
Interventions: Oxymorphone ER
First posted: 2009-07-02
Last updated: 2023-05-09
Results first posted: 2023-05-09

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Rapid Visual Information Processing (RVP) Sensitivity [A']	1 and 3 hours postdose	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 \[ms\]).
Primary	Rapid Visual Information Processing (RVP) Response Latency	1 and 3 hours postdose	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 \[ms\]).
Secondary	Spatial Recognition Memory (SRM) Test Percentage of Correct Hits	1 and 3 hours postdose	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 \[ms\]).
Secondary	Spatial Recognition Memory (SRM) Test Response Latency	1 and 3 hours postdose	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 \[ms\]).
Secondary	Spatial Working Memory (SWM) Test Total Errors	1 and 3 hours postdose	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).
Secondary	Spatial Working Memory (SWM) Test Strategy Score	1 and 3 hours postdose	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)

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rapid Visual Information Processing (RVP) Sensitivity [A']	1 and 3 hours postdose	Completers	probability of detecting sequence	MEAN
PRIMARY	Rapid Visual Information Processing (RVP) Response Latency	1 and 3 hours postdose	Completers	milliseconds	MEAN
SECONDARY	Spatial Recognition Memory (SRM) Test Percentage of Correct Hits	1 and 3 hours postdose	completers	percentage of hits	MEAN
SECONDARY	Spatial Recognition Memory (SRM) Test Response Latency	1 and 3 hours postdose	completers	milliseconds	MEAN
SECONDARY	Spatial Working Memory (SWM) Test Total Errors	1 and 3 hours postdose	completers	number of errors	MEAN
SECONDARY	Spatial Working Memory (SWM) Test Strategy Score	1 and 3 hours postdose	completers	number of boxes	MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Rapid Visual Information Processing (RVP) Sensitivity [A']	Oxymorphone 40 mg With High-fat Meal	1-hour post dose	0.94	Standard Error 0.01	probability of detecting sequence
Rapid Visual Information Processing (RVP) Sensitivity [A']	Oxymorphone 40 mg Fasting	1-hour post dose	0.93	Standard Error 0.01	probability of detecting sequence
Rapid Visual Information Processing (RVP) Sensitivity [A']	Oxymorphone 40 mg With High-fat Meal	3-hours post dose	0.95	Standard Error 0.01	probability of detecting sequence
Rapid Visual Information Processing (RVP) Sensitivity [A']	Oxymorphone 40 mg Fasting	3-hours post dose	0.96	Standard Error 0.01	probability of detecting sequence
Rapid Visual Information Processing (RVP) Response Latency	Oxymorphone 40 mg With High-fat Meal	1-hour post dose	447.52	Standard Error 17.47	milliseconds
Rapid Visual Information Processing (RVP) Response Latency	Oxymorphone 40 mg Fasting	1-hour post dose	455.96	Standard Error 18.63	milliseconds
Rapid Visual Information Processing (RVP) Response Latency	Oxymorphone 40 mg With High-fat Meal	3-hours post dose	422.33	Standard Error 15.21	milliseconds
Rapid Visual Information Processing (RVP) Response Latency	Oxymorphone 40 mg Fasting	3-hours post dose	424.62	Standard Error 18.84	milliseconds
Spatial Recognition Memory (SRM) Test Percentage of Correct Hits	Oxymorphone 40 mg With High-fat Meal	1-hour post dose	81.67	Standard Error 1.78	percentage of hits
Spatial Recognition Memory (SRM) Test Percentage of Correct Hits	Oxymorphone 40 mg Fasting	1-hour post dose	83.17	Standard Error 1.37	percentage of hits

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Oxymorphone 40 mg (Fed vs Fasting)	30
Overall Study	COMPLETED	Oxymorphone 40 mg (Fed vs Fasting)	30
Overall Study	NOT COMPLETED	Oxymorphone 40 mg (Fed vs Fasting)	0

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Oxymorphone 40 mg With High-fat Meal	30
Total, all-cause mortality	Oxymorphone 40 mg Fasting	30
Total, other adverse events	Oxymorphone 40 mg With High-fat Meal	30
Total, other adverse events	Oxymorphone 40 mg Fasting	30
Total, serious adverse events	Oxymorphone 40 mg With High-fat Meal	30
Total, serious adverse events	Oxymorphone 40 mg Fasting	30

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24330343	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Oxymorphone 40 mg With High-fat Meal vs Oxymorphone 40 mg Fasting: deaths from any cause	Trial comparisons
Oxymorphone 40 mg With High-fat Meal vs Oxymorphone 40 mg Fasting: serious adverse events	Trial comparisons

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Rapid Visual Information Processing	Primary outcome	ConductCognition
Spatial Recognition Memory	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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