Post-operative Efficacy and Safety Study
This study has been completed.
Sponsor:
Endo Pharmaceuticals
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904085
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
| 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
N/A
|
Drug: Oxymorphone IR
5 mg
|
|
Placebo Comparator: Placebo
N/A
|
Drug: Oxymorphone IR
5 mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | Sr. Director, Clinical R&D |
| ClinicalTrials.gov Identifier: | NCT00904085 History of Changes |
| Other Study ID Numbers: | EN3203-008 |
| Study First Received: | May 15, 2009 |
| Last Updated: | February 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Oxymorphone Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013