Clinical trial NCT00226395: Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Keywords: oxymorphone
acute pain
abdominal surgery
opioids
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Time to discontinuation due to all causes
Secondary outcomes:
measure: The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
measure: - 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
measure: - 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
measure: - Time (in hours) to First Perceptible Pain Relief
measure: - Time (in hours) to Meaningful Pain Relief
measure: - Hourly Pain Relief Scores
measure: - Hourly Pain Intensity Difference Scores
measure: The following are the secondary endpoints during the multiple dosing phase:
measure: - Mean average pain intensity scores collected during the dosing intervals.
measure: - Mean current pain intensity (VAS) collected during the dosing intervals.
measure: - Patient's global evaluation of study medication at the end of study.
measure: - Physician's global evaluation of study medication at the end of study.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Brookwood Medical Center
state: Alabama
city: Birmingham
country: United States
facility: The Medical Center, Dept. Clinical research
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Women's Health Associates
state: Alabama
city: Phoenix
country: United States
facility: Arrowhead Community Hospital
state: Arizona
city: Phoenix
country: United States
facility: John C Lincoln Hospital
state: Arizona
city: Phoenix
country: United States
facility: Paradise Valley Hospital
state: Arizona
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: Palm Springs
country: United States
facility: Palm West Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Medical Park Hospital
state: North Carolina
city: Pittsburgh
country: United States
facility: Univ. Pittsburgh Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univ. Pittsburgh Medical center
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Hermann Memorial City Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Cottonwood Hospital
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Salt Lake City
country: United States
facility: McKay-Dee Hospital
state: Utah
Study officials:
References: