Post-operative PainPhase 3NCT00904085
Post-operative Efficacy and Safety Study
A Phase 3 study testing Oxymorphone IR in people with Post-operative Pain, run by Endo USA Inc., a Keenova Therapeutics Company.
Trial summary
The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Oxymorphone IR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jun 2003
- Phase
- Phase 3
- 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
- Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy
- Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe,
- Have been informed of the nature of the study and provided written informed consent
Who cannot join
- Have a positive pregnancy test
- Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines
- Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication.
- Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin [>325 mg/day], acetaminophen, and NSAIDs)
- Have received MAOI drugs within 2 weeks prior to dosing
- Not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs, Serotonin reuptake inhibitors, Amphetamines used for ADHD
About this study
Official title: A Randomized, Double-blind Evaluation of the Analgesic Efficacy and Safety of a Low Dose Oxymorphone Immediate Release in Patients Following Ambulatory Arthroscopic Knee Surgery
The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.
- Conditions
- Post-operative Pain
- Being tested
- Oxymorphone IR
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymorphone IRDrug
5 mg
| Study group | Role | What they receive |
|---|---|---|
| Oxymorphone | Active comparator | Not described Receives: Drug: Oxymorphone IR |
| Placebo | Placebo comparator | Not described Receives: Drug: Oxymorphone IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity (SPID) Visual Analog Scale (VAS)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startApr 2003
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sr. Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904085
- Sponsor's protocol ID
- EN3203-008
- Status last verified
- Feb 2010
- First submitted
- 15 May 2009
- Last updated
- 15 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Evaluation of the Analgesic Efficacy and Safety of a Low Dose Oxymorphone Immediate Release in Patients Following Ambulatory Arthroscopic Knee Surgery
- ClinicalTrials.gov ID
- NCT00904085
- Acronym / sponsor ID
- EN3203-008
- Conditions
- Post-operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 19 May 2009 (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 study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxymorphone | Active comparator | Drug: Oxymorphone IR |
| Placebo | Placebo comparator | Drug: Oxymorphone IR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy
- Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe,
- Have been informed of the nature of the study and provided written informed consent
Key exclusion criteria (6 listed)
- Have a positive pregnancy test
- Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines
- Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication.
- Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin [>325 mg/day], acetaminophen, and NSAIDs)
- Have received MAOI drugs within 2 weeks prior to dosing
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 |
|---|---|---|
| Oxymorphone IR5 mg | Drug | Oxymorphone, Placebo |
Primary outcome
Sum of Pain Intensity (SPID) Visual Analog Scale (VAS)
Time frame: 2 months
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 15 Feb 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.
Sr. Director study director
Endo USA Inc., a Keenova Therapeutics Company
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxymorphone IR in people with Post-operative Pain, run by Endo USA Inc., a Keenova Therapeutics Company.
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 3 inclusion and 6 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 15 Feb 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Sum of Pain Intensity (SPID) Visual Analog Scale (VAS) (time frame: 2 months). 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 15 Feb 2010.