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

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxymorphone immediate release
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring oxymorphone, acute pain, abdominal surgery, opioids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brookwood Medical Center
  • The Medical Center, Dept. Clinical research
  • Montgomery Women's Health Associates
  • Arrowhead Community Hospital
  • John C Lincoln Hospital
  • Paradise Valley Hospital
  • Glendale Adventist Medical Center
  • Saddleback Memorial Medical Center
  • Huntington Memorial Hospital
  • Palm West Hospital
  • Sacred Heart Hospital
  • Duke University Medical Center
  • Forsyth Medical Center
  • Medical Park Hospital
  • Univ. Pittsburgh Hospital
  • Univ. Pittsburgh Medical center
  • Memorial Hermann Memorial City Hospital
  • The Methodist Hospital
  • Cottonwood Hospital
  • LDS Hospital
  • McKay-Dee Hospital

Outcomes

Primary Outcome Measures

Time to discontinuation due to all causes

Secondary Outcome Measures

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.

Full Information

First Posted
September 23, 2005
Last Updated
February 12, 2010
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00226395
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
oxymorphone, acute pain, abdominal surgery, opioids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
320 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Brookwood Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
The Medical Center, Dept. Clinical research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Montgomery Women's Health Associates
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36113
Country
United States
Facility Name
Arrowhead Community Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
John C Lincoln Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Paradise Valley Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Saddleback Memorial Medical Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91109
Country
United States
Facility Name
Palm West Hospital
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Medical Park Hospital
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Univ. Pittsburgh Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Univ. Pittsburgh Medical center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Memorial Hermann Memorial City Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cottonwood Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
McKay-Dee Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

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

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