NCT00904085

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for phase_3 postoperative-pain

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_3 postoperative-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

Enrollment Period

2 months

First QC Date

May 15, 2009

Last Update Submit

February 12, 2010

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

  • Sum of Pain Intensity (SPID) Visual Analog Scale (VAS)

    2 months

Study Arms (2)

Oxymorphone

ACTIVE COMPARATOR
Drug: Oxymorphone IR

Placebo

PLACEBO COMPARATOR
Drug: Oxymorphone IR

Interventions

Oxymorphone IRDRUG

5 mg

OxymorphonePlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sr. Director

    Endo Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 19, 2009

Study Start

April 1, 2003

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

February 15, 2010

Record last verified: 2010-02