Status:
COMPLETED
A Randomized, Open-Label, Single-Dose, Small Study to Evaluate the Safety and Effectiveness of Hydromorphone in Patients With Short Term, Moderate to Severe Postoperative Pain
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Pain, Postoperative
Orthopedic Procedures
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this small study was to investigate the safety and effectiveness of OROS hydromorphone HCI for the treatment of short-term, moderate to severe postoperative pain following total knee re...
Detailed Description
This was a multicenter, randomized (patients are assigned different treatments based on chance), open-label, single dose small study. During the 36 hour study period, concomitant analgesic (pain) medi...
Eligibility Criteria
Inclusion
- Patients undergoing primary, unilateral total knee replacement surgery where use of opioid analgesics for short-term postoperative pain is required
- At baseline must be able to tolerate oral liquids, swallow a tablet, and have the presence of bowel sounds upon examination
- Patients must demonstrate stable vital signs immediately before dosing with OROS hydromorphone HCI
- At baseline pain intensity upon movement must be scored by the patient as 2 or 3 (moderate or severe) on the Pain Intensity Rating Scale
- At baseline patients receiving regional anesthetics/analgesics must demonstrate recovery from the motor and sensory effects of the nerve blockade
- Patients must be administered OROS hydromorphone HCI between 6 and 48 hours following completion of surgery
- Patients should expect to remain hospitalized for 36 hours after study drug administration.
Exclusion
- Patients either intolerant of hydromorphone or who have experienced an anaphylactic IgE-mediated immune response (e.g. hives, wheezing, angioedema or bronchospasms) to any opioid agonist
- Patients having previously undergone the following major surgery for high tibial osteotomy, knee arthroplasty to the affected knee
- Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs
- Patients who are pregnant or breast-feeding. A negative pregnancy test is required prior to administration of the study medication in females of childbearing potential
- Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition
- Patients with clinically significant impaired renal, hepatic, or hematological function
- adrenocortical insufficiency
- uncontrolled hypothyroidism or hyperthyroidism, or clinically significant urinary obstruction
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2001
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00411307
End Date
October 1 2001
Last Update
April 27 2010
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