- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226395
Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
December 29, 2023 updated by: Endo Pharmaceuticals
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
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.
Study Overview
Detailed Description
Following abdominal surgery and after sufficient washout from post-surgical analgesia, patients were randomized to one of the following four treatment groups; 1) oxymorphone IR 10 mg, 2) oxymorphone IR 20 mg, 3) oxycodone IR 15 mg, or 4) placebo.
Total duration of treatment was 48 hours.
Patients were required to take the study medication every 4-6 hours.
After the first dose, periodic pain assessments were performed for the first six hours.
Subsequently, patients were required to assess their current pain intensity and average pain intensity since the last dose of study medication just prior to every dose.
Study Type
Interventional
Enrollment
320
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35205
- Brookwood Medical Center
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Birmingham, Alabama, United States, 35205
- The Medical Center, Dept. Clinical research
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Montgomery, Alabama, United States, 36113
- Montgomery Women's Health Associates
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Arizona
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Phoenix, Arizona, United States, 85023
- Arrowhead Community Hospital
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Phoenix, Arizona, United States, 85023
- John C Lincoln Hospital
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Phoenix, Arizona, United States, 85023
- Paradise Valley Hospital
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California
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Glendale, California, United States, 91206
- Glendale Adventist Medical Center
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Laguna Hills, California, United States, 92653
- Saddleback Memorial Medical Center
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Pasadena, California, United States, 91109
- Huntington Memorial Hospital
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Florida
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Palm Springs, Florida, United States, 33461
- Palm West Hospital
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Pensacola, Florida, United States, 32514
- Sacred Heart Hospital
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Winston-Salem, North Carolina, United States, 27103
- Forsyth Medical Center
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Winston-Salem, North Carolina, United States, 27103
- Medical Park Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Univ. Pittsburgh Hospital
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Pittsburgh, Pennsylvania, United States, 15232
- Univ. Pittsburgh Medical center
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Texas
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Houston, Texas, United States, 77030
- The Methodist Hospital
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Houston, Texas, United States, 77024
- Memorial Hermann Memorial City Hospital
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Utah
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Salt Lake City, Utah, United States, 84124
- Cottonwood Hospital
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Salt Lake City, Utah, United States, 84124
- LDS Hospital
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Salt Lake City, Utah, United States, 84124
- McKay-Dee Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Time to discontinuation due to all causes
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Secondary Outcome Measures
Outcome Measure |
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The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
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- 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
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- 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
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- Time (in hours) to First Perceptible Pain Relief
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- Time (in hours) to Meaningful Pain Relief
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- Hourly Pain Relief Scores
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- Hourly Pain Intensity Difference Scores
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The following are the secondary endpoints during the multiple dosing phase:
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- Mean average pain intensity scores collected during the dosing intervals.
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- Mean current pain intensity (VAS) collected during the dosing intervals.
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- Patient's global evaluation of study medication at the end of study.
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- Physician's global evaluation of study medication at the end of study.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion
August 1, 2005
Study Registration Dates
First Submitted
September 23, 2005
First Submitted That Met QC Criteria
September 23, 2005
First Posted (Estimated)
September 27, 2005
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EN3203-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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