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

• Status: Completed
• Trial end date: 2001-10-01
• Target enrollment: 0
• Participant gender: All

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 replacement surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Hydromorphone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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