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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00226395
First received: September 23, 2005
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Acute Pain
Drug: Oxymorphone immediate release
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

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.

Estimated Enrollment: 320
Study Start Date: September 2004
Estimated Study Completion Date: August 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226395

Locations
United States, Alabama
Brookwood Medical Center
Birmingham, Alabama, United States, 35205
The Medical Center, Dept. Clinical research
Birmingham, Alabama, United States, 35205
Montgomery Women's Health Associates
Montgomery, Alabama, United States, 36113
United States, Arizona
Arrowhead Community Hospital
Phoenix, Arizona, United States, 85023
John C Lincoln Hospital
Phoenix, Arizona, United States, 85023
Paradise Valley Hospital
Phoenix, Arizona, United States, 85023
United States, California
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
Huntington Memorial Hospital
Pasadena, California, United States, 91109
United States, Florida
Palm West Hospital
Palm Springs, Florida, United States, 33461
Sacred Heart Hospital
Pensacola, Florida, United States, 32514
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Medical Park Hospital
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Univ. Pittsburgh Hospital
Pittsburgh, Pennsylvania, United States, 15213
Univ. Pittsburgh Medical center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Memorial Hermann Memorial City Hospital
Houston, Texas, United States, 77024
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
Cottonwood Hospital
Salt Lake City, Utah, United States, 84124
LDS Hospital
Salt Lake City, Utah, United States, 84124
McKay-Dee Hospital
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Endo Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00226395     History of Changes
Other Study ID Numbers: EN3203-009
Study First Received: September 23, 2005
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
oxymorphone
acute pain
abdominal surgery
opioids

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Oxymorphone
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014