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CompletedNCT00904085Updated Feb 15, 2010

Post-operative Efficacy and Safety Study

A Phase 3 interventional study of Oxymorphone IR in Post-operative Pain, sponsored by Endo USA Inc., a Keenova Therapeutics Company. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-15.

Sponsored by Endo USA Inc., a Keenova Therapeutics Company (part of Keenova Therapeutics plc) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.

02

Conditions studied

  • Post-operative Pain

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03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 122 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Browse Endo USA Inc. studies →All Keenova Therapeutics plc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy
  • Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe,
  • Have been informed of the nature of the study and provided written informed consent

Exclusion criteria

Exclusion Criteria:

  • Have a positive pregnancy test
  • Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines
  • Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication.
  • Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin [>325 mg/day], acetaminophen, and NSAIDs)
  • Have received MAOI drugs within 2 weeks prior to dosing
  • Not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs, Serotonin reuptake inhibitors, Amphetamines used for ADHD
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
122 participants (actual)

Study arms

  • Active comparator
    Oxymorphone

    Drug: Oxymorphone IR

  • Placebo comparator
    Placebo

    Drug: Oxymorphone IR

Interventions

06

What researchers measure

Primary outcomes

  1. Sum of Pain Intensity (SPID) Visual Analog Scale (VAS)

    Time frame: 2 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2003, a primary completion of Jun 2003 and a completion of Jun 2003. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2009
First posted
May 19, 2009
Start
Apr 2003
Primary completionActual
Jun 2003
CompletionActual
Jun 2003
Last update
Feb 15, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00904085
Lead sponsor
Endo USA Inc., a Keenova Therapeutics Company
First posted
May 19, 2009
Start date
Apr 2003
Primary completion
Jun 2003
Completion
Jun 2003
Last update
Feb 15, 2010

Study contacts

Sr. Director
study director · Endo USA Inc., a Keenova Therapeutics Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Oxymorphone

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