Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
Randomized, Double-Blind, Placebo- and Active-Control, Single- and Multiple-Dose Evaluation of the Analgesic Efficacy and Safety of Oxymorphone Immediate Release (IR) Tablets in Patients With Moderate/Severe Pain Following Abdominal Surgery
1 other identifier
interventional
320
1 country
21
Brief Summary
The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2004
Shorter than P25 for phase_3
21 active sites
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
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 23, 2005
CompletedFirst Posted
Study publicly available on registry
September 27, 2005
CompletedJanuary 2, 2024
December 1, 2023
September 23, 2005
December 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to discontinuation due to all causes
Secondary Outcomes (12)
The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
- 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
- 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
- Time (in hours) to First Perceptible Pain Relief
- Time (in hours) to Meaningful Pain Relief
- +7 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients 18 years of age or older
- Patients undergoing surgery through an abdominal incision of at least 3 cm who are expected to be hospitalized for at least 36 hours and are expected to subsequently require at least 48 hours of oral opioid therapy.
- Washout of at least 45 minutes for parenteral and 4 hours for IM analgesia.
- Initial pain intensity score of at least 50 mm on a 100-mm VAS and a categorical pain rating of moderate or severe on a scale of none, mild, moderate, or severe.
- Written informed consent.
You may not qualify if:
- Known allergy or significant reaction to opioids.
- History of chronic opioid use or opioid abuse within 6 months prior to study entry.
- History of alcohol or substance abuse within the last 3 years.
- Have been a participant in a study of an investigational drug or device within 30 days prior to study entry.
- Have been a previous participant in an oxymorphone clinical trial.
- Are currently taking or have taken a monoamine oxidase inhibitor (MAOI) drug within 2 weeks prior to study entry.
- Are currently taking or have taken St. John's Wort \>1000 mg/day within 2 days prior to study entry.
- Use of long-acting oral and parenteral analgesics (opioid, non-opioid or non-steroidal anti-inflammatory drug \[NSAID\]) within 12 hours (at least 24 hours for cyclooxygenase-2 \[COX 2\] analgesics) prior to receiving study medication.
- Are not stabilized on the following medications for at least 4 weeks prior to dosing: tricyclic antidepressant drugs; serotonin reuptake inhibitors; amphetamines used for attention-deficit hyperactivity disorder (ADHD)
- Have a history of seizure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Brookwood Medical Center
Birmingham, Alabama, 35205, United States
The Medical Center, Dept. Clinical research
Birmingham, Alabama, 35205, United States
Montgomery Women's Health Associates
Montgomery, Alabama, 36113, United States
Arrowhead Community Hospital
Phoenix, Arizona, 85023, United States
John C Lincoln Hospital
Phoenix, Arizona, 85023, United States
Paradise Valley Hospital
Phoenix, Arizona, 85023, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Saddleback Memorial Medical Center
Laguna Hills, California, 92653, United States
Huntington Memorial Hospital
Pasadena, California, 91109, United States
Palm West Hospital
Palm Springs, Florida, 33461, United States
Sacred Heart Hospital
Pensacola, Florida, 32514, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Medical Park Hospital
Winston-Salem, North Carolina, 27103, United States
Univ. Pittsburgh Hospital
Pittsburgh, Pennsylvania, 15213, United States
Univ. Pittsburgh Medical center
Pittsburgh, Pennsylvania, 15232, United States
Memorial Hermann Memorial City Hospital
Houston, Texas, 77024, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Cottonwood Hospital
Salt Lake City, Utah, 84124, United States
LDS Hospital
Salt Lake City, Utah, 84124, United States
McKay-Dee Hospital
Salt Lake City, Utah, 84124, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 23, 2005
First Posted
September 27, 2005
Study Start
September 1, 2004
Study Completion
August 1, 2005
Last Updated
January 2, 2024
Record last verified: 2023-12