Efficacy and Safety of Oxymorphone Immediate Release in Post-Surgical Acute Pain
Information source: Endo Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Pain
Intervention: Oxymorphone immediate release (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Endo Pharmaceuticals
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to discontinuation due to all causes
Secondary outcome: 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 - Hourly Pain Relief Scores - Hourly Pain Intensity Difference Scores The following are the secondary endpoints during the multiple dosing phase: - Mean average pain intensity scores collected during the dosing intervals. - Mean current pain intensity (VAS) collected during the dosing intervals. - Patient’s global evaluation of study medication at the end of study. - Physician’s global evaluation of study medication at the end of study.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Montgomery Women's Health Associates, Montgomery, Alabama 36113, United States
The Medical Center, Dept. Clinical research, Birmingham, Alabama 35205, United States
Brookwood Medical Center, Birmingham, Alabama 35205, United States
Arrowhead Community Hospital, Phoenix, Arizona 85023, United States
Paradise Valley Hospital, Phoenix, Arizona 85023, United States
John C Lincoln Hospital, Phoenix, Arizona 85023, United States
Saddleback Memorial Medical Center, Laguna Hills, California 92653, United States
Huntington Memorial Hospital, Pasadena, California 91109, United States
Glendale Adventist Medical Center, Glendale, California 91206, United States
Palm West Hospital, Palm Springs, Florida 33461, United States
Sacred Heart Hospital, Pensacola, Florida 32514, United States
Forsyth Medical Center, Winston Salem, North Carolina 27103, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Medical Park Hospital, Winston Salem, North Carolina 27103, United States
Univ. Pittsburgh Medical center, Pittsburgh, Pennsylvania 15232, United States
Univ. Pittsburgh Hospital, Pittsburgh, Pennsylvania 15213, United States
Memorial Hermann Memorial City Hospital, Houston, Texas 77024, United States
The Methodist Hospital, Houston, Texas 77030, United States
McKay-Dee Hospital, Salt Lake City, Utah 84124, United States
LDS Hospital, Salt Lake City, Utah 84124, United States
Cottonwood Hospital, Salt Lake City, Utah 84124, United States
Additional Information
Starting date: September 2004
Ending date: August 2005
Last updated: September 23, 2005
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