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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00226395
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Endo Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Oxymorphone immediate release Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2004
Study Completion Date : August 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Time to discontinuation due to all causes

Secondary Outcome Measures :
  1. The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
  2. - 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
  3. - 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
  4. - Time (in hours) to First Perceptible Pain Relief
  5. - Time (in hours) to Meaningful Pain Relief
  6. - Hourly Pain Relief Scores
  7. - Hourly Pain Intensity Difference Scores
  8. The following are the secondary endpoints during the multiple dosing phase:
  9. - Mean average pain intensity scores collected during the dosing intervals.
  10. - Mean current pain intensity (VAS) collected during the dosing intervals.
  11. - Patient's global evaluation of study medication at the end of study.
  12. - Physician's global evaluation of study medication at the end of study.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226395


Locations
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Sponsors and Collaborators
Endo Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00226395    
Other Study ID Numbers: EN3203-009
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Keywords provided by Endo Pharmaceuticals:
oxymorphone
acute pain
abdominal surgery
opioids
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Oxymorphone
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia