Acute PainPhase 3NCT00226395
Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
A Phase 3 study testing Oxymorphone immediate release in people with Acute Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 21 sites in United States.
Trial summary
The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Oxymorphone immediate release
- How many people
- 320 participants
- Where
- 21 sitesUnited States
- Study dates
- Sep 2004to Aug 2005
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18 years of age or older
- Patients undergoing surgery through an abdominal incision of at least 3 cm who are expected to be hospitalized for at least 36 hours and are expected to subsequently require at least 48 hours of oral opioid therapy.
- Washout of at least 45 minutes for parenteral and 4 hours for IM analgesia.
- Initial pain intensity score of at least 50 mm on a 100-mm VAS and a categorical pain rating of moderate or severe on a scale of none, mild, moderate, or severe.
- Written informed consent.
Who cannot join
- Known allergy or significant reaction to opioids.
- History of chronic opioid use or opioid abuse within 6 months prior to study entry.
- History of alcohol or substance abuse within the last 3 years.
- Have been a participant in a study of an investigational drug or device within 30 days prior to study entry.
- Have been a previous participant in an oxymorphone clinical trial.
- Are currently taking or have taken a monoamine oxidase inhibitor (MAOI) drug within 2 weeks prior to study entry.
Show all 10Show fewer
- Are currently taking or have taken St. John's Wort >1000 mg/day within 2 days prior to study entry.
- Use of long-acting oral and parenteral analgesics (opioid, non-opioid or non-steroidal anti-inflammatory drug [NSAID]) within 12 hours (at least 24 hours for cyclooxygenase-2 [COX 2] analgesics) prior to receiving study medication.
- Are not stabilized on the following medications for at least 4 weeks prior to dosing: tricyclic antidepressant drugs; serotonin reuptake inhibitors; amphetamines used for attention-deficit hyperactivity disorder (ADHD)
- Have a history of seizure.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Brookwood Medical Center
Birmingham, Alabama, 35205
The Medical Center, Dept. Clinical research
Birmingham, Alabama, 35205
Duke University Medical Center
Durham, North Carolina, 27710
Glendale Adventist Medical Center
Glendale, California, 91206
Memorial Hermann Memorial City Hospital
Houston, Texas, 77024
The Methodist Hospital
Houston, Texas, 77030
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Montgomery Women's Health Associates
Montgomery, Alabama, 36113
Palm West Hospital
Palm Springs, Florida, 33461
Huntington Memorial Hospital
Pasadena, California, 91109
Sacred Heart Hospital
Pensacola, Florida, 32514
Arrowhead Community Hospital
Phoenix, Arizona, 85023
John C Lincoln Hospital
Phoenix, Arizona, 85023
Paradise Valley Hospital
Phoenix, Arizona, 85023
Univ. Pittsburgh Hospital
Pittsburgh, Pennsylvania, 15213
Univ. Pittsburgh Medical center
Pittsburgh, Pennsylvania, 15232
Cottonwood Hospital
Salt Lake City, Utah, 84124
LDS Hospital
Salt Lake City, Utah, 84124
McKay-Dee Hospital
Salt Lake City, Utah, 84124
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Medical Park Hospital
Winston-Salem, North Carolina, 27103
About this study
Official title: Randomized, Double-Blind, Placebo- and Active-Control, Single- and Multiple-Dose Evaluation of the Analgesic Efficacy and Safety of Oxymorphone Immediate Release (IR) Tablets in Patients With Moderate/Severe Pain Following Abdominal Surgery
The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.
Read the detailed description
Following abdominal surgery and after sufficient washout from post-surgical analgesia, patients were randomized to one of the following four treatment groups; 1) oxymorphone IR 10 mg, 2) oxymorphone IR 20 mg, 3) oxycodone IR 15 mg, or 4) placebo. Total duration of treatment was 48 hours. Patients were required to take the study medication every 4-6 hours. After the first dose, periodic pain assessments were performed for the first six hours. Subsequently, patients were required to assess their current pain intensity and average pain intensity since the last dose of study medication just prior to every dose.
- Conditions
- Acute Pain
- Being tested
- Oxymorphone immediate release
- Keywords
- oxymorphone, acute pain, abdominal surgery, opioids
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymorphone immediate releaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discontinuation due to all causes
Secondary outcomes (12)
The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
- 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
- 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
- Time (in hours) to First Perceptible Pain Relief
- Time (in hours) to Meaningful Pain Relief
- Hourly Pain Relief Scores
- Hourly Pain Intensity Difference Scores
The following are the secondary endpoints during the multiple dosing phase:
- Mean average pain intensity scores collected during the dosing intervals.
- Mean current pain intensity (VAS) collected during the dosing intervals.
- Patient's global evaluation of study medication at the end of study.
- Physician's global evaluation of study medication at the end of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startSep 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 320 participants
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226395
- Sponsor's protocol ID
- EN3203-009
- Status last verified
- Dec 2023
- First submitted
- 23 Sep 2005
- Last updated
- 2 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo- and Active-Control, Single- and Multiple-Dose Evaluation of the Analgesic Efficacy and Safety of Oxymorphone Immediate Release (IR) Tablets in Patients With Moderate/Severe Pain Following Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00226395
- Acronym / sponsor ID
- EN3203-009
- Conditions
- Acute Pain
- Keywords
- oxymorphone, acute pain, abdominal surgery, opioids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Aug 2005
- First posted
- 27 Sep 2005 (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 is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.
Detailed description
Following abdominal surgery and after sufficient washout from post-surgical analgesia, patients were randomized to one of the following four treatment groups; 1) oxymorphone IR 10 mg, 2) oxymorphone IR 20 mg, 3) oxycodone IR 15 mg, or 4) placebo. Total duration of treatment was 48 hours. Patients were required to take the study medication every 4-6 hours. After the first dose, periodic pain assessments were performed for the first six hours. Subsequently, patients were required to assess their current pain intensity and average pain intensity since the last dose of study medication just prior to every dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients 18 years of age or older
- Patients undergoing surgery through an abdominal incision of at least 3 cm who are expected to be hospitalized for at least 36 hours and are expected to subsequently require at least 48 hours of oral opioid therapy.
- Washout of at least 45 minutes for parenteral and 4 hours for IM analgesia.
- Initial pain intensity score of at least 50 mm on a 100-mm VAS and a categorical pain rating of moderate or severe on a scale of none, mild, moderate, or severe.
- Written informed consent.
Key exclusion criteria (10 listed)
- Known allergy or significant reaction to opioids.
- History of chronic opioid use or opioid abuse within 6 months prior to study entry.
- History of alcohol or substance abuse within the last 3 years.
- Have been a participant in a study of an investigational drug or device within 30 days prior to study entry.
- Have been a previous participant in an oxymorphone clinical trial.
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 immediate release | Drug | – |
Primary outcome
Time to discontinuation due to all causes
12 secondary outcomes
The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
- 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
- 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
- Time (in hours) to First Perceptible Pain Relief
- Time (in hours) to Meaningful Pain Relief
- Hourly Pain Relief Scores
- Hourly Pain Intensity Difference Scores
The following are the secondary endpoints during the multiple dosing phase:
- Mean average pain intensity scores collected during the dosing intervals.
- Mean current pain intensity (VAS) collected during the dosing intervals.
- Patient's global evaluation of study medication at the end of study.
- Physician's global evaluation of study medication at the end of study.
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 2 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxymorphone immediate release in people with Acute Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 21 sites in United States.
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 5 inclusion and 10 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Time to discontinuation due to all causes. 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 2 Jan 2024.