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Post-operative Efficacy and Safety Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00904085
First Posted: May 19, 2009
Last Update Posted: February 15, 2010
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.
Information provided by:
Endo Pharmaceuticals
  Purpose
The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.

Condition Intervention Phase
Post-operative Pain Drug: Oxymorphone IR Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Evaluation of the Analgesic Efficacy and Safety of a Low Dose Oxymorphone Immediate Release in Patients Following Ambulatory Arthroscopic Knee Surgery

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Sum of Pain Intensity (SPID) Visual Analog Scale (VAS) [ Time Frame: 2 months ]

Enrollment: 122
Study Start Date: April 2003
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxymorphone Drug: Oxymorphone IR
5 mg
Placebo Comparator: Placebo Drug: Oxymorphone IR
5 mg

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy
  • Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe,
  • Have been informed of the nature of the study and provided written informed consent

Exclusion Criteria:

  • Have a positive pregnancy test
  • Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines
  • Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication.
  • Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin [>325 mg/day], acetaminophen, and NSAIDs)
  • Have received MAOI drugs within 2 weeks prior to dosing
  • Not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs, Serotonin reuptake inhibitors, Amphetamines used for ADHD
  Contacts and Locations
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): NCT00904085


Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Sr. Director Endo Pharmaceuticals
  More Information

Responsible Party: Sr. Director, Clinical R&D
ClinicalTrials.gov Identifier: NCT00904085     History of Changes
Other Study ID Numbers: EN3203-008
First Submitted: May 15, 2009
First Posted: May 19, 2009
Last Update Posted: February 15, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Oxymorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia