NCT00801398 is a Phase 3 clinical trial of Oxymorphone IR in Postoperative Pain, sponsored by Endo Pharmaceuticals.

Who is sponsoring NCT00801398?

NCT00801398 is sponsored by Endo Pharmaceuticals.

What drugs are being tested in NCT00801398?

Interventions in NCT00801398: Oxymorphone IR.

What condition does NCT00801398 study?

NCT00801398 studies Postoperative Pain.

Is NCT00801398 still recruiting?

NCT00801398 is currently completed. Last updated 27 February 2019.

Are results published for NCT00801398?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-02-27 · How we verify

NCT00801398

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

Completed Phase 3 Results posted Last updated 27 February 2019

What this trial tests

Phase 3 trial testing Oxymorphone IR in Postoperative Pain in 58 participants. Completed in 18 April 2011.

Timeline

17 February 2009

Primary endpoint
18 April 2011

18 April 2011

Quick facts

Lead sponsor	Endo Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	17 February 2009
Primary completion	18 April 2011
Estimated completion	18 April 2011
Sites	11 locations across United States

Drugs / interventions tested

Oxymorphone IR — full drug profile →

Conditions studied

Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

Endo Pharmaceuticals — full company profile →

Who can join

Adults 12 to 17, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Primary · Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination

Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet

15 Minutes Post Dose/ 15 Minutes Post First Dose

Group	Value	95% CI
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	-13.4	± 22.86
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	-22.2	± 17.79
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	-21.6	± 13.59
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	-16.7	± 23.31
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	0.5	± 9.56
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	-17.4	± 13.46

30 Minutes Post Dose/30 Minutes Post First Dose

Group	Value	95% CI
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	-12.8	± 36.90
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	-13.7	± 28.32
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	-22.9	± 19.87
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	-18.3	± 25.84
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	3.1	± 22.33
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	-23.0	± 15.94

1 Hour Post Dose/1 Hour Post First Dose

Group	Value	95% CI
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	-24.70	± 36.74
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	-17.4	± 28.64
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	-29.8	± 20.02
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	-22.0	± 25.13
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	-7.8	± 18.90
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	-28.3	± 15.00

2 Hours Post Dose/2 Hours Post First Dose

Group	Value	95% CI
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	-19.3	± 29.07
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	-29.0	± 25.55
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	-33.8	± 20.10
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	-14.4	± 36.56
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	-6.3	± 22.04
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	-12.9	± 34.37

3 Hours Post Dose/3 Hours Post First Dose

Group	Value	95% CI
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	-35.4	± 26.97
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	-29.3	± 20.21
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	-28.6	± 16.75
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	-25.8	± 40.17
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	-15.5	± 19.67
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	-24.7	± 20.70

4 Hours Post Dose/4 Hours Post First Dose

Group	Value	95% CI
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	-36.2	± 25.03
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	-19.5	± 45.96
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	-31.5	± 14.20
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	-34.8	± 31.65
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	-7.5	± 29.33
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	-10.8	± 20.64

6 Hrs Post Dose or Rescue/6 Hours Post First Dose

Group	Value	95% CI
Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet	-34.4	± 25.32
Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet	-3.0	± 21.85
Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet	-18.2	± 18.73
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	-41.0	± NA
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	-6.0	± 20.22
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	-38.3	± 9.45

Multiple Dose #1

Group	Value	95% CI
Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet	-28.0	± 14.11
Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet	-15.0	± 17.72
Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet	-25.2	± 11.65

Subjects Taking Rescue Medication Primary · first dose through 48 hours after first dose

Percentages are based on the number of subjects in each treatment group.

Group	Value	95% CI
Single Dose of Oxymorphone IR: 5mg Tablet	9
Single Dose of Oxymorphone IR: 10mg Tablet	9
Single Dose of Oxymorphone IR: 15mg Tablet	7
Multiple Dose of Oxymorphone: 5mg Tablet	5
Multiple Dose of Oxymorphone IR: 10mg Tablet	6
Multiple Dose of Oxymorphone IR: 15mg Tablet	4

AUC(0-t) of Single Dose of Oxymorphone by Treatment Group Secondary · Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule

Group	Value	95% CI
Single Dose of Oxymorphone IR: 5mg Tablet	6.395	± 6.0752
Single Dose of Oxymorphone IR: 10mg Tablet	3.766	± 2.2587
Single Dose of Oxymorphone IR: 15mg Tablet	67.040	± 150.7979
Single Dose of 6-OH-Oxymorphone: 5mg Tablet	1.544	± 1.8794
6-OH-Oxymorphone (ng/mL): 10mg	3.040	± 1.1625
6-OH-Oxymorphone (ng/mL): 15mg	7.354	± 3.3255

AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group Secondary · Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration

Group	Value	95% CI
Single Dose of Oxymorphone IR: 5mg Tablet	7.632	± 6.6828
Single Dose of Oxymorphone IR: 10mg Tablet	10.223	± 6.5195
Single Dose of Oxymorphone IR: 15mg Tablet	109.294	± 257.5421
Single Dose of 6-OH-Oxymorphone: 5mg Tablet	4.987	± 7.5732
Single Dose of 6-OH-Oxymorphone: 10mg Tablet	8.692	± 10.2430
Single Dose 6-OH-Oxymorphone: 15mg Tablet	12.795	± 8.8385

Cmax of Single Dose of Oxymorphone by Treatment Group Secondary · Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval

Group	Value	95% CI
Single Dose of Oxymorphone IR: 5mg Tablet	1.243	± 1.2192
Single Dose of Oxymorphone IR: 10mg Tablet	0.828	± 0.6892
Single Dose of Oxymorphone IR: 15mg Tablet	5.295	± 10.6386
Single Dose of 6-OH-Oxymorphone: 5mg Tablet	0.314	± 0.3276
Single Dose of 6-OH-Oxymorphone: 10mg Tablet	0.487	± 0.2853
Single Dose 6-OH-Oxymorphone: 15mg Tablet	0.940	± 0.5212

Tmax of Single Dose of Oxymorphone by Treatment Group Secondary · Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Tmax: The time at which Cmax was observed

Group	Value	95% CI
Single Dose of Oxymorphone IR: 5mg Tablet	4.898	± 3.9645
Single Dose of Oxymorphone IR: 10mg Tablet	3.681	± 2.4102
Single Dose of Oxymorphone IR: 15mg Tablet	6.193	± 6.3784
Single Dose of 6-OH-Oxymorphone: 5mg Tablet	3.885	± 2.7228
Single Dose of 6-OH-Oxymorphone: 10mg Tablet	4.631	± 3.7051
Single Dose 6-OH-Oxymorphone: 15mg Tablet	3.785	± 3.2552

Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group Secondary · Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only)

Group	Value	95% CI
Single Dose of Oxymorphone IR: 5mg Tablet	0.209	± 0.2552
Single Dose of Oxymorphone IR: 10mg Tablet	0.214	± 0.2962
Single Dose of Oxymorphone IR: 15mg Tablet	0.073	± 0.0549
Single Dose of 6-OH-Oxymorphone: 5mg Tablet	0.281	± 0.2072
Single Dose of 6-OH-Oxymorphone: 10mg Tablet	0.101	± 0.0965
Single Dose 6-OH-Oxymorphone: 15mg Tablet	0.042	± 0.0234

Terminal Half-life of Single Dose of Oxymorphone by Treatment Group Secondary · Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)

Group	Value	95% CI
Single Dose of Oxymorphone IR: 5mg Tablet	12.099	± 9.9336
Single Dose of Oxymorphone IR: 10mg Tablet	15.900	± 18.2533
Single Dose of Oxymorphone IR: 15mg Tablet	19.974	± 22.4488
Single Dose of 6-OH-Oxymorphone: 5mg Tablet	19.215	± 37.3737
Single Dose of 6-OH-Oxymorphone: 10mg Tablet	23.635	± 33.6381
Single Dose 6-OH-Oxymorphone: 15mg Tablet	22.520	± 15.3063

Adverse events — posted to ClinicalTrials.gov

Time frame: All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Dose of Oxymorphone IR: 5mg Tablet

Serious: 0/13 (0%)

Deaths: 0/13

Single Dose of Oxymorphone IR: 10mg Tablet

Serious: 1/9 (11%)

Deaths: 0/9

Single Dose of Oxymorphone IR: 15mg Tablet

Serious: 1/11 (9%)

Deaths: 0/11

Multiple Dose of Oxymorphone IR: 5mg Tablet

Serious: 1/9 (11%)

Deaths: 0/9

Multiple Dose of Oxymorphone IR: 10mg Tablet

Serious: 1/8 (13%)

Deaths: 0/8

Multiple Dose of Oxymorphone IR: 15mg Tablet

Serious: 0/8 (0%)

Deaths: 0/8

Serious adverse events (10 terms)

Reaction	System	Single Dose of Oxymorphone…	Single Dose of Oxymorphone…	Single Dose of Oxymorphone…	Multiple Dose of Oxymorpho…	Multiple Dose of Oxymorpho…	Multiple Dose of Oxymorpho…
Atelectasis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Fat embolism	Injury, poisoning and procedural complications	—	—	—	—	—	—
Failure of implant	Injury, poisoning and procedural complications	—	—	—	—	—	—
Pupils unequal	Eye disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Somatosensory evoked	Investigations	—	—	—	—	—	—
Monoplegia	Nervous system disorders	—	—	—	—	—	—
Spinal cord oedema	Nervous system disorders	—	—	—	—	—	—

Other adverse events (17 terms — click to expand)

Reaction	System	Single Dose of Oxymorphone…	Single Dose of Oxymorphone…	Single Dose of Oxymorphone…	Multiple Dose of Oxymorpho…	Multiple Dose of Oxymorpho…	Multiple Dose of Oxymorpho…
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Urinary retention	Renal and urinary disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Oxygen saturation decreased	Investigations	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—	—	—
Sedation	Nervous system disorders	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—

Most-reported serious reactions: Atelectasis, Fat embolism, Failure of implant, Pupils unequal, Anaemia, Vision blurred, Headache, Somatosensory evoked.

Data from ClinicalTrials.gov NCT00801398 adverse events section.

Sponsor's own description

When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40). This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00801398 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Endo Pharmaceuticals
Last refreshed: 27 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00801398.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing