A Phase 4 interventional study of opana then darvocet then placebo and opana then placebo then darvocet in Lumbar Spinal Stenosis, sponsored by University of Rochester. Terminated at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-03-25.
Sponsored by University of Rochester · Phase 4, Interventional, and Treatment
The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to improvement in duration and distance of walking.
A computer-generated randomization plan was used for assignment of subjects to one of six treatment sequences (4 subjects per sequence): oxymorphone/propoxyphene/placebo, oxymorphone/placebo/propoxyphene, placebo/oxymorphone/propoxyphene, placebo/propoxyphene/oxymorphone, propoxyphene/oxymorphone/placebo, or propoxyphene/placebo/oxymorphone. One dose of blinded study drug (opana, propoxypehen, or placebo) was given at study days 1, 5, and 9. The primary endpoint was time to first symptoms of moderate intensity (NRS ≥ 4/10) during treadmill ambulation. Ambulation assessment was performed during the screening visit. Ambulation assessment was also performed 90 minutes after administration of study drug on days 1, 5 and 9, to evaluate pain intensity associated with walking as well as distance covered by the patients. Quantitative assessment of ambulation was conducted on a treadmill at 0° ramp incline at 1.2 miles per hour (mph). Measurement of self-reported symptom severity using the NRS at baseline, and every 30 seconds for a maximum of 15 minutes was recorded. The following information was also recorded: time to first symptoms, total ambulation time. The examination was stopped after 15 minutes or at the onset of severe symptoms. Severe symptoms were defined as the level of discomfort that would make patients stop walking in usual life situations. No one was encouraged or prompted to continue walking beyond this point. Patients were instructed to walk with an upright posture. They were not permitted to lean forward or hold onto the handrails during the examination. Secondary outcome measures included area under the curve of present pain intensity with ambulation at each specified time point, final pain intensity with walking, walking tolerance, time to return to baseline pain level after ambulation, as well as the results of a series of pain related questionnaires including: Visual Analog Scale (VAS), Patient Global Assessment (PGA), NRS, Roland Morris Disability Questionnaire (RMDQ), modified Brief Pain Inventory short form (mBPI-sf), Oswestry Disability Index (ODI), and Swiss Spinal Stenosis (SSS).
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Exclusion Criteria:
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Drug: opana then darvocet then placebo
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Drug: opana then placebo then darvocet
Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Drug: placebo then opana then darvocet
Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Drug: Placebo then darvocet then opana
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Drug: Darvocet then opana then placebo
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Drug: Darvocet then placebo then opana
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Time to First Symptoms (Tfirst) of Moderate Pain
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.
Time frame: study visit
Area Under the Curve
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked.
Time frame: study visit
Total Distance
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.
Time frame: study visit
Recovery Time
After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.
Time frame: study visit
Visual Analog Scale (VAS)
The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.
Time frame: study visit
Patient Global Assessment (PGA)
Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.
Time frame: study visit
Roland Morris Disability Questionnaire (RMDQ)
The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).
Time frame: study visit
Modified Brief Pain Inventory (mBPI)- Interference Score
The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities.
Time frame: study visit
Oswestry Disability Index (ODI) Score
The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability.
Time frame: study visit
Swiss Spinal Stenosis Score- Symptom Severity
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.
Time frame: study visit
Swiss Spinal Stenosis Score- Physical Function
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.
Time frame: study visit
Final Pain
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity.
Time frame: study visit
08 December 2007 (initial IRB approval) to 26 August 2011\* (final study results) First patient enrolled: 12 June 2008. Last patient completed: 12 October 2010 \*Study terminated on 29 November 2010 due to US Food and Drug Administration (FDA) removing active control (Darvocet) from the U.S. market.
| Milestone | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 4 | 4 |
| Completed | 4 | 4 | 3 | 4 | 2 | 4 |
| Not completed | 0 | 0 | 1 | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 1 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 1 | 0 |
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.
| minutes | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Time to First Symptoms (Tfirst) of Moderate Pain | 1.73 ± 1.68 | 3.02 ± 2.90 | 3.93 ± 3.22 | 2.65 ± 3.23 | 0.83 ± 0.73 | 5.43 ± 4.28 |
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked.
| units on a scale * minutes | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Area Under the Curve | 76.0 ± 39.5 | 95.7 ± 27.7 | 95.0 ± 35.9 | 86.4 ± 39.0 | 123.3 ± 6.3 | 79.6 ± 31.5 |
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.
| meters | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Total Distance | 266.6 ± 191.3 | 249.5 ± 109.4 | 177.9 ± 139.1 | 290.1 ± 176.0 | 160.8 ± 96.5 | 294.8 ± 133.2 |
After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.
| minutes | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Recovery Time | 1.10 ± 0.98 | 1.50 ± 1.37 | 2.02 ± 2.68 | 1.58 ± 1.22 | 2.15 ± 1.18 | 1.57 ± 1.19 |
The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.
| units on a scale | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Visual Analog Scale (VAS) | 51.3 ± 22.0 | 57.9 ± 25.7 | 56.2 ± 28.6 | 46.7 ± 24.0 | 63.3 ± 31.0 | 55.1 ± 30.7 |
Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.
| units on a scale | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Patient Global Assessment (PGA) | 2.8 ± 0.6 | 2.8 ± 1.0 | 3.1 ± 1.2 | 2.6 ± 0.5 | 3.3 ± 0.5 | 2.6 ± 1.1 |
The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).
| units on a scale | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Roland Morris Disability Questionnaire (RMDQ) | 12.8 ± 4.4 | 15.3 ± 5.0 | 13.2 ± 4.1 | 15.2 ± 2.7 | 13.7 ± 3.6 | 7.4 ± 4.3 |
The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities.
| units on a scale | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Modified Brief Pain Inventory (mBPI)- Interference Score | 3.7 ± 2.0 | 4.2 ± 1.4 | 2.7 ± 0.8 | 4.3 ± 1.3 | 6.2 ± 1.0 | 2.8 ± 2.6 |
The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability.
| units on a scale | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Oswestry Disability Index (ODI) Score | 37.9 ± 9.7 | 98.4 ± 5.7 | 38.0 ± 6.6 | 44.1 ± 9.7 | 37.0 ± 2.8 | 29.7 ± 13.3 |
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.
| units on a scale | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Swiss Spinal Stenosis Score- Symptom Severity | 2.6 ± 0.6 | 2.9 ± 0.6 | 3.2 ± 0.3 | 3.2 ± 0.7 | 3.6 ± 0.5 | 2.9 ± 0.6 |
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.
| units on a scale | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Swiss Spinal Stenosis Score- Physical Function | 2.5 ± 0.4 | 2.5 ± 0.2 | 2.6 ± 0.6 | 2.6 ± 0.5 | 2.6 ± 0.2 | 2.2 ± 0.2 |
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity.
| units on a scale | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| Final Pain | 4.6 ± 2.2 | 6.6 ± 1.6 | 6.2 ± 2.7 | 6.7 ± 2.5 | 8.0 ± 0.6 | 7.1 ± 1.9 |
Collected over AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | — | 0/4 (0%) | 0/4 (0%) |
| Opana Then Placebo Then Darvocet | — | 0/4 (0%) | 2/4 (50%) |
| Placebo Then Opana Then Darvocet | — | 0/3 (0%) | 0/3 (0%) |
| Placebo Then Darvocet Then Opana | — | 0/4 (0%) | 0/4 (0%) |
| Darvocet Then Opana Then Placebo | — | 0/2 (0%) | 0/2 (0%) |
| Darvocet Then Placebo Then Opana | — | 0/4 (0%) | 1/4 (25%) |
| Event | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana |
|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 0/4 | 1/4 | 0/3 | 0/4 | 0/2 | 0/4 |
| SomnolenceGeneral disorders | 0/4 | 1/4 | 0/3 | 0/4 | 0/2 | 0/4 |
| DizzinessGeneral disorders | 0/4 | 0/4 | 0/3 | 0/4 | 0/2 | 1/4 |
| Age, Categorical(Participants) | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 1 | 0 | 1 | 2 | 4 |
| >=65 years | 4 | 4 | 3 | 4 | 3 | 2 | 20 |
| Age, Continuous(years) | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana | Total |
|---|---|---|---|---|---|---|---|
| Mean | 69.5 ± 4 | 73.0 ± 3.2 | 76.0 ± 12 | 70.0 ± 4.8 | 76.0 ± 15.2 | 63.3 ± 6.8 | 71.3 ± 9.0 |
| Sex: Female, Male(Participants) | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana | Total |
|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 3 | 3 | 3 | 2 | 12 |
| Male | 4 | 3 | 1 | 1 | 1 | 2 | 12 |
| Region of Enrollment(participants) | Opana Then Darvocet Then Placebo | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana | Total |
|---|---|---|---|---|---|---|---|
| United States | 4 | 4 | 4 | 4 | 4 | 4 | 24 |
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