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Post-operative Efficacy and Safety Study

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ClinicalTrials.gov Identifier: NCT00904085
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Endo Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Post-operative Pain Drug: Oxymorphone IR Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
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
Study Start Date : April 2003
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Oxymorphone Drug: Oxymorphone IR
5 mg
Placebo Comparator: Placebo Drug: Oxymorphone IR
5 mg



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


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

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

Responsible Party: Sr. Director, Clinical R&D
ClinicalTrials.gov Identifier: NCT00904085     History of Changes
Other Study ID Numbers: EN3203-008
First Posted: May 19, 2009    Key Record Dates
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