Trial · NCT00955110

Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)

NCT00955110, Phase 4, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2011-07-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin). Trials, record NCT00955110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00955110

On this page

Trial

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

Title: Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
NCT number: NCT00955110
Status: Completed
Phases: Phase 4
Enrollment: 78 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Healthy
Interventions: Oxymorphone ER, Oxycodone CR, Placebo, Hydromorphone
First posted: 2009-08-07
Last updated: 2017-10-05
Results first posted: 2011-07-14

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	High VAS - Emax (mm)	High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.	The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar ("I am feeling high"). The ends of the line were marked with the descriptive anchors ("Definitely not" and "Definitely so"). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	High VAS - Emax (mm)	High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.	Per Protocol population: Subjects who received all 5 treatments and who had no major protocol deviations or other circumstances that would exclude them from the analysis. The pharmacokinetic and pharmacodynamic analyses were performed using the Per Protocol population. No imputation of missing values was performed.	mm	MEAN

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Spread	Units
High VAS - Emax (mm)	Placebo	23.1	Standard Deviation 33.29	mm
High VAS - Emax (mm)	Oxymorphone ER 15 mg	30.6	Standard Deviation 36.17	mm
High VAS - Emax (mm)	Oxymorphone ER 30 mg	62.5	Standard Deviation 33.22	mm
High VAS - Emax (mm)	Oxycodone CR 30 mg	81.4	Standard Deviation 23.17	mm
High VAS - Emax (mm)	Oxycodone CR 60 mg	93.0	Standard Deviation 12.94	mm

Source ClinicalTrials.gov

Participant flow11

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

Period	Milestone	Group	Participants
Qualification Phase	STARTED	All Subjects	78
Qualification Phase	COMPLETED	All Subjects	54
Qualification Phase	NOT COMPLETED	All Subjects	24
Treatment Phase	STARTED	All Subjects	41
Treatment Phase	Placebo	All Subjects	38
Treatment Phase	Oxymorphone ER 15 mg	All Subjects	37
Treatment Phase	Oxymorphone ER 30 mg	All Subjects	38
Treatment Phase	Oxycodone CR 30 mg	All Subjects	40
Treatment Phase	Oxycodone CR 60 mg	All Subjects	40
Treatment Phase	COMPLETED	All Subjects	35

1 to 10 of 11Source ClinicalTrials.gov

See all 11 participant flow

Adverse events90

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

Type	Event	Organ system	Group	Affected	At risk
other	Dry mouth	Gastrointestinal disorders	Treatment Phase Placebo	0	38
other	Dry mouth	Gastrointestinal disorders	Treatment Phase Oxymorphone ER 15 mg	0	37
other	Dry mouth	Gastrointestinal disorders	Treatment Phase Oxymorphone ER 30mg	0	38
other	Dry mouth	Gastrointestinal disorders	Treatment Phase Oxycodone CR 30mg	0	40
other	Dry mouth	Gastrointestinal disorders	Treatment Phase Oxycodone CR 60 mg	4	40
other	Nausea	Gastrointestinal disorders	Treatment Phase Placebo	0	38
other	Nausea	Gastrointestinal disorders	Treatment Phase Oxymorphone ER 15 mg	2	37
other	Nausea	Gastrointestinal disorders	Treatment Phase Oxymorphone ER 30mg	2	38
other	Nausea	Gastrointestinal disorders	Treatment Phase Oxycodone CR 30mg	6	40
other	Nausea	Gastrointestinal disorders	Treatment Phase Oxycodone CR 60 mg	18	40

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment Phase Placebo
Total, all-cause mortality	Treatment Phase Oxymorphone ER 15 mg
Total, all-cause mortality	Treatment Phase Oxymorphone ER 30mg
Total, all-cause mortality	Treatment Phase Oxycodone CR 30mg
Total, all-cause mortality	Treatment Phase Oxycodone CR 60 mg
Total, other adverse events	Treatment Phase Placebo	13	38
Total, other adverse events	Treatment Phase Oxymorphone ER 15 mg	22	37
Total, other adverse events	Treatment Phase Oxymorphone ER 30mg	28	38
Total, other adverse events	Treatment Phase Oxycodone CR 30mg	35	40
Total, other adverse events	Treatment Phase Oxycodone CR 60 mg	39	40

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21102969	DERIVED

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 comparisons0

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

None in this release.

Tests0

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

None in this release.

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00955110

GET https://conductscience.org/api/trials/v1/NCT00955110/events?page=2

API reference For AI assistants