Trial Outcomes & Findings for Lumbar Stenosis Outcomes Research II (NCT NCT00652093)
NCT ID: NCT00652093
Last Updated: 2016-03-25
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
study visit
Results posted on
2016-03-25
Participant Flow
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.
Forty-three subjects signed the Research Subject Review Board (local IRB) approved consent form. Nineteen subjects failed screening and did not meet inclusion criteria. Twenty-four subjects met radiographic and treadmill criteria for neurogenic claudication and were randomized. Of these, 21 subjects completed all phases of the study
Participant milestones
| Measure |
Opana Then Darvocet Then Placebo
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.
|
Opana Then Placebo Then Darvocet
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.
|
Placebo Then Opana 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.
|
Placebo Then Darvocet Then Opana
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.
|
Darvocet Then Opana Then Placebo
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.
|
Darvocet Then Placebo Then Opana
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
3
|
4
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Opana Then Darvocet Then Placebo
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.
|
Opana Then Placebo Then Darvocet
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.
|
Placebo Then Opana 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.
|
Placebo Then Darvocet Then Opana
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.
|
Darvocet Then Opana Then Placebo
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.
|
Darvocet Then Placebo Then Opana
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Lumbar Stenosis Outcomes Research II
Baseline characteristics by cohort
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=4 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=4 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 4 • n=93 Participants
|
73.0 years
STANDARD_DEVIATION 3.2 • n=4 Participants
|
76.0 years
STANDARD_DEVIATION 12 • n=27 Participants
|
70.0 years
STANDARD_DEVIATION 4.8 • n=483 Participants
|
76.0 years
STANDARD_DEVIATION 15.2 • n=36 Participants
|
63.3 years
STANDARD_DEVIATION 6.8 • n=10 Participants
|
71.3 years
STANDARD_DEVIATION 9.0 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
4 participants
n=27 Participants
|
4 participants
n=483 Participants
|
4 participants
n=36 Participants
|
4 participants
n=10 Participants
|
24 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: study visitPopulation: The analyses included all 24 enrolled randomized subjects based on inclusion/exclusion criteria except for three who withdrew from trial prior to completion of study. One dropped out (physician decision) due to an adverse event (AE) (dizzy) and two dropped due to scheduling. This singular AE is not included in the AE reporting below.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Time to First Symptoms (Tfirst) of Moderate Pain
|
1.73 minutes
Standard Deviation 1.68
|
3.02 minutes
Standard Deviation 2.90
|
3.93 minutes
Standard Deviation 3.22
|
2.65 minutes
Standard Deviation 3.23
|
0.83 minutes
Standard Deviation 0.73
|
5.43 minutes
Standard Deviation 4.28
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve
|
76.0 units on a scale * minutes
Standard Deviation 39.5
|
95.7 units on a scale * minutes
Standard Deviation 27.7
|
95.0 units on a scale * minutes
Standard Deviation 35.9
|
86.4 units on a scale * minutes
Standard Deviation 39.0
|
123.3 units on a scale * minutes
Standard Deviation 6.3
|
79.6 units on a scale * minutes
Standard Deviation 31.5
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Total Distance
|
266.6 meters
Standard Deviation 191.3
|
249.5 meters
Standard Deviation 109.4
|
177.9 meters
Standard Deviation 139.1
|
290.1 meters
Standard Deviation 176.0
|
160.8 meters
Standard Deviation 96.5
|
294.8 meters
Standard Deviation 133.2
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Recovery Time
|
1.10 minutes
Standard Deviation 0.98
|
1.50 minutes
Standard Deviation 1.37
|
2.02 minutes
Standard Deviation 2.68
|
1.58 minutes
Standard Deviation 1.22
|
2.15 minutes
Standard Deviation 1.18
|
1.57 minutes
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Visual Analog Scale (VAS)
|
51.3 units on a scale
Standard Deviation 22.0
|
57.9 units on a scale
Standard Deviation 25.7
|
56.2 units on a scale
Standard Deviation 28.6
|
46.7 units on a scale
Standard Deviation 24.0
|
63.3 units on a scale
Standard Deviation 31.0
|
55.1 units on a scale
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Patient Global Assessment (PGA)
|
2.8 units on a scale
Standard Deviation 0.6
|
2.8 units on a scale
Standard Deviation 1.0
|
3.1 units on a scale
Standard Deviation 1.2
|
2.6 units on a scale
Standard Deviation 0.5
|
3.3 units on a scale
Standard Deviation 0.5
|
2.6 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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).
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Roland Morris Disability Questionnaire (RMDQ)
|
12.8 units on a scale
Standard Deviation 4.4
|
15.3 units on a scale
Standard Deviation 5.0
|
13.2 units on a scale
Standard Deviation 4.1
|
15.2 units on a scale
Standard Deviation 2.7
|
13.7 units on a scale
Standard Deviation 3.6
|
7.4 units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Modified Brief Pain Inventory (mBPI)- Interference Score
|
3.7 units on a scale
Standard Deviation 2.0
|
4.2 units on a scale
Standard Deviation 1.4
|
2.7 units on a scale
Standard Deviation 0.8
|
4.3 units on a scale
Standard Deviation 1.3
|
6.2 units on a scale
Standard Deviation 1.0
|
2.8 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Oswestry Disability Index (ODI) Score
|
37.9 units on a scale
Standard Deviation 9.7
|
98.4 units on a scale
Standard Deviation 5.7
|
38.0 units on a scale
Standard Deviation 6.6
|
44.1 units on a scale
Standard Deviation 9.7
|
37.0 units on a scale
Standard Deviation 2.8
|
29.7 units on a scale
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: study visitThe 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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Swiss Spinal Stenosis Score- Symptom Severity
|
2.6 units on a scale
Standard Deviation 0.6
|
2.9 units on a scale
Standard Deviation 0.6
|
3.2 units on a scale
Standard Deviation 0.3
|
3.2 units on a scale
Standard Deviation 0.7
|
3.6 units on a scale
Standard Deviation 0.5
|
2.9 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Swiss Spinal Stenosis Score- Physical Function
|
2.5 units on a scale
Standard Deviation 0.4
|
2.5 units on a scale
Standard Deviation 0.2
|
2.6 units on a scale
Standard Deviation 0.6
|
2.6 units on a scale
Standard Deviation 0.5
|
2.6 units on a scale
Standard Deviation 0.2
|
2.2 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: study visitPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Opana Then Darvocet Then Placebo
n=4 Participants
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.
|
Opana Then Placebo Then Darvocet
n=4 Participants
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.
|
Placebo Then Opana Then Darvocet
n=3 Participants
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.
|
Placebo Then Darvocet Then Opana
n=4 Participants
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.
|
Darvocet Then Opana Then Placebo
n=2 Participants
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.
|
Darvocet Then Placebo Then Opana
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Final Pain
|
4.6 units on a scale
Standard Deviation 2.2
|
6.6 units on a scale
Standard Deviation 1.6
|
6.2 units on a scale
Standard Deviation 2.7
|
6.7 units on a scale
Standard Deviation 2.5
|
8.0 units on a scale
Standard Deviation 0.6
|
7.1 units on a scale
Standard Deviation 1.9
|
Adverse Events
Placebo Then Darvocet Then Opana
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Darvocet Then Opana Then Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Darvocet Then Placebo Then Opana
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Opana Then Darvocet Then Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opana Then Placebo Then Darvocet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Then Opana Then Darvocet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Then Darvocet Then Opana
n=4 participants at risk
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.
|
Darvocet Then Opana Then Placebo
n=2 participants at risk
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.
|
Darvocet Then Placebo Then Opana
n=4 participants at risk
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.
|
Opana Then Darvocet Then Placebo
n=4 participants at risk
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.
|
Opana Then Placebo Then Darvocet
n=4 participants at risk
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.
|
Placebo Then Opana Then Darvocet
n=3 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/2 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/4 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/4 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
25.0%
1/4 • Number of events 1 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/3 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
|
General disorders
Somnolence
|
0.00%
0/4 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/2 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/4 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/4 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
25.0%
1/4 • Number of events 1 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/3 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
|
General disorders
Dizziness
|
0.00%
0/4 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/2 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
25.0%
1/4 • Number of events 1 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/4 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/4 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
0.00%
0/3 • AEs were captured for each subject from the first study visit through the final study visit (i.e. day 1 through day 9).
|
Additional Information
Dr. John D. Markman, MD
Translational Pain Research, University of Rochester Medical Center
Phone: 585-276-3616
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place