Pain, PostoperativePhase 2NCT00411307
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
A Phase 2 study testing OROS hydromorphone HCI in people with Pain, Postoperative and Orthopedic Procedures, run by Alza Corporation, DE, USA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Orthopedic Procedures, Analgesia
- What is being tested?
- OROS hydromorphone HCI
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Oct 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Pain, Postoperative, Orthopedic Procedures, Analgesia
- Being tested
- OROS hydromorphone HCI
- Keywords
- Analgesia, Postoperative pain
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROS hydromorphone HCIDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alza Corporation Clinical Trial, Study director, ALZA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411307
- Sponsor's protocol ID
- CR013267
- Status last verified
- Apr 2010
- First submitted
- 12 Dec 2006
- Last updated
- 27 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00411307
- Acronym / sponsor ID
- CR013267
- Conditions
- Pain, Postoperative, Orthopedic Procedures, Analgesia
- Keywords
- Analgesia, Postoperative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study completion
- Oct 2001 (actual)
- First posted
- 14 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OROS hydromorphone HCI | Drug | – |
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
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alza Corporation Clinical Trial study director
ALZA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OROS hydromorphone HCI in people with Pain, Postoperative and Orthopedic Procedures, run by Alza Corporation, DE, USA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2010.