Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226395
• Other study ID #: EN3203-009
• Status: Completed
• Phase: Phase 3
• Start date: September 2004
• Est. completion date: August 2005

Study information

• Verified date: December 2023
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Oxymorphone immediate release

Locations

Country	Name	City	State
United States	Brookwood Medical Center	Birmingham	Alabama
United States	The Medical Center, Dept. Clinical research	Birmingham	Alabama
United States	Duke University Medical Center	Durham	North Carolina
United States	Glendale Adventist Medical Center	Glendale	California
United States	Memorial Hermann Memorial City Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	Saddleback Memorial Medical Center	Laguna Hills	California
United States	Montgomery Women's Health Associates	Montgomery	Alabama
United States	Palm West Hospital	Palm Springs	Florida
United States	Huntington Memorial Hospital	Pasadena	California
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Arrowhead Community Hospital	Phoenix	Arizona
United States	John C Lincoln Hospital	Phoenix	Arizona
United States	Paradise Valley Hospital	Phoenix	Arizona
United States	Univ. Pittsburgh Hospital	Pittsburgh	Pennsylvania
United States	Univ. Pittsburgh Medical center	Pittsburgh	Pennsylvania
United States	Cottonwood Hospital	Salt Lake City	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	McKay-Dee Hospital	Salt Lake City	Utah
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Medical Park Hospital	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to discontinuation due to all causes
Secondary	The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
Secondary	- 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
Secondary	- 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
Secondary	- Time (in hours) to First Perceptible Pain Relief
Secondary	- Time (in hours) to Meaningful Pain Relief
Secondary	- Hourly Pain Relief Scores
Secondary	- Hourly Pain Intensity Difference Scores
Secondary	The following are the secondary endpoints during the multiple dosing phase:
Secondary	- Mean average pain intensity scores collected during the dosing intervals.
Secondary	- Mean current pain intensity (VAS) collected during the dosing intervals.
Secondary	- Patient's global evaluation of study medication at the end of study.
Secondary	- Physician's global evaluation of study medication at the end of study.