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
Information source: Alza Corporation, DE, USA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative; Orthopedic Procedures; Analgesia
Intervention: OROS hydromorphone HCI (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Alza Corporation, DE, USA Official(s) and/or principal investigator(s): Alza Corporation Clinical Trial, Study Director, Affiliation: ALZA
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.
Clinical Details
Official title: A Randomized, Open-Label, Single-Dose, Pilot Study to Evaluate the Safety and Efficacy of OROS Hydromorphone in Patients With Acute, Moderate-to-Severe Postoperative Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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 outcome: 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
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) medications and physical therapy were recorded in the patient's case
report form. The study duration for each patient was 36 hours after a single dose of OROS
hydromorphone HCI had been administered. After surgery, eligible patients had to tolerate
liquids, swallow a tablet, and have audible bowel sounds. Before OROS hydromorphone HCI was
administered, all analgesic medications were discontinued and patients with a pain score of
2(moderate pain) or 3 (severe pain) upon movement were eligible to enter the study and
receive a single oral dose of OROS hydromorphone HCI. Patients had to have stable heart
rates, blood pressure, respiration, oxygen saturation greater than or equal to 94% and
patients who had undergone regional anesthesia had to have motor and sensory recovery from
nerve blockade. Qualifying patients were given OROS hydromorphone HCI between 6 and 48
hours after completion of the surgical procedure. Patients were randomized into 3 groups
(OROS hydromorphone HCI 8, 16, and 32 mg). The precise time of OROS hydromorphone HCI
administration was considered time zero. To maintain consistency, dosing was to occur
between 6 am and 2 pm, if possible. Following study drug administration, patients could be
given rescue medication of oral hydromorphone immediate-release tablets (2 or 4 mg) for
breakthrough pain as needed. Oxygen saturation, vital signs, pain relief ratings, and pain
intensity ratings at rest and upon movement were obtained at 2-hour time intervals during
the first 8 hours following study drug administration, and at 4 hour intervals from 8 to 36
hours following study drug administration. The study concluded 36 hours after dosing, at
which time a global evaluation of pain relief was obtained from each patient. One single
dose of OROS hydromorphone HCI (8, 16, or 32 mg) administered orally at the beginning of the
36 hour study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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Last updated: April 26, 2010
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