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

NCT00411307 | Completed Phase 2

• 1 other identifier: CR013267
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 replacement surgery.

Conditions

Pain, Postoperative; Orthopedic Procedures; Analgesia

Keywords

Analgesia; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Variables measured included: Total number of doses/amount of rescue medication hydromorphone (immediate release) taken for breakthrough pain during 36 hours post OROS hydromorphone (slow release) administration

Secondary Outcomes (1)

• Variables measured included:Pain relief scores; Pain intensity scores;Patient's rating of sleep interference;global evaluation of analgesia; oxygen saturation; vital signs and adverse events

Interventions

OROS hydromorphone HCI DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Alza Corporation Clinical Trial

  ALZA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 14, 2006
• Study Completion: October 1, 2001
• Last Updated: April 27, 2010

Record last verified: 2010-04