Page last updated: 2024-12-07

acetaminophen, dextropropoxyphene, drug combination

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

acetaminophen, dextropropoxyphene, drug combination: RN is for mixture of propoxyphene.HCl & paracetamol; [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID123857
SCHEMBL ID2524073
MeSH IDM0495989

Synonyms (15)

Synonym
distalgesic
acetaminophen, dextropropoxyphene, drug combination
di-antalvic
39400-85-6
propoxyphene-apap
propoxyphene hydrochloride and acetaminophen
cosalgesic
deano. 9278
acetamide, n-(4-hydroxyphenyl)-, mixt. with (s-(r*,s*))-3-(dimethylamino)-2-methyl-1-phenyl-1-(phenylmethyl)propyl propanoate hydrochloride
di-antalvi
dolene ap 65
SCHEMBL2524073
[(2s,3r)-4-(dimethylamino)-3-methyl-1,2-diphenylbutan-2-yl] propanoate;n-(4-hydroxyphenyl)acetamide;hydrochloride
DTXSID60960075
n-(4-hydroxyphenyl)ethanimidic acid--4-(dimethylamino)-3-methyl-1,2-diphenylbutan-2-yl propanoate--hydrogen chloride (1/1/1)

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"Dihydrocodeine and tramadol are particularly toxic in overdose and codeine is also relatively toxic."( Relative toxicity of analgesics commonly used for intentional self-poisoning: A study of case fatality based on fatal and non-fatal overdoses.
Bankhead, C; Casey, D; Clements, C; Ferrey, A; Fuller, A; Geulayov, G; Gunnell, D; Hawton, K; Kapur, N; Ness, J; Wells, C, 2019
)
0.51

Dosage Studied

ExcerptRelevanceReference
" This indicates that although the preparation is hepatotoxic when taken acutely in overdose, in chronic therapeutic dosage it appears to be free from this hazard."( Liver function in patients on long-term paracetamol (co-proxamol) analgesia.
Hutchinson, DR; Parke, DV; Schilds, AF, 1986
)
0.27
" The mean elimination half-life of dextropropoxyphene after multiple dosing was 35."( Pharmacokinetics of dextropropoxyphene and nordextropropoxyphene in elderly hospital patients after single and multiple doses of distalgesic. Preliminary analysis of results.
Crome, P; Flanagan, RJ; Gain, R; Ghurye, R, 1984
)
0.27
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (96)

TimeframeStudies, This Drug (%)All Drugs %
pre-199041 (42.71)18.7374
1990's25 (26.04)18.2507
2000's19 (19.79)29.6817
2010's11 (11.46)24.3611
2020's0 (0.00)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 9.44

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be weak demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index9.44 (24.57)
Research Supply Index4.81 (2.92)
Research Growth Index4.25 (4.65)
Search Engine Demand Index0.00 (26.88)
Search Engine Supply Index0.00 (0.95)

This Compound (9.44)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials16 (15.09%)5.53%
Reviews6 (5.66%)6.00%
Case Studies36 (33.96%)4.05%
Observational0 (0.00%)0.25%
Other48 (45.28%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Lumbar Stenosis Outcomes Research II: Opana IR Versus Placebo and Active Control (Darvocet) for the Treatment of Walking Impairment in Lumbar Spinal Stenosis: A Double-Blind Randomized, Cross-Over Trial [NCT00652093]Phase 424 participants (Actual)Interventional2008-03-31Terminated(stopped due to Removal of Darvocet from US market)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00652093 (12) [back to overview]Area Under the Curve
NCT00652093 (12) [back to overview]Final Pain
NCT00652093 (12) [back to overview]Modified Brief Pain Inventory (mBPI)- Interference Score
NCT00652093 (12) [back to overview]Oswestry Disability Index (ODI) Score
NCT00652093 (12) [back to overview]Patient Global Assessment (PGA)
NCT00652093 (12) [back to overview]Recovery Time
NCT00652093 (12) [back to overview]Roland Morris Disability Questionnaire (RMDQ)
NCT00652093 (12) [back to overview]Swiss Spinal Stenosis Score- Physical Function
NCT00652093 (12) [back to overview]Swiss Spinal Stenosis Score- Symptom Severity
NCT00652093 (12) [back to overview]Time to First Symptoms (Tfirst) of Moderate Pain
NCT00652093 (12) [back to overview]Total Distance
NCT00652093 (12) [back to overview]Visual Analog Scale (VAS)

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. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale * minutes (Mean)
Opana Then Darvocet Then Placebo76.0
Opana Then Placebo Then Darvocet95.7
Placebo Then Opana Then Darvocet95.0
Placebo Then Darvocet Then Opana86.4
Darvocet Then Opana Then Placebo123.3
Darvocet Then Placebo Then Opana79.6

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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. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo4.6
Opana Then Placebo Then Darvocet6.6
Placebo Then Opana Then Darvocet6.2
Placebo Then Darvocet Then Opana6.7
Darvocet Then Opana Then Placebo8.0
Darvocet Then Placebo Then Opana7.1

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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. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo3.7
Opana Then Placebo Then Darvocet4.2
Placebo Then Opana Then Darvocet2.7
Placebo Then Darvocet Then Opana4.3
Darvocet Then Opana Then Placebo6.2
Darvocet Then Placebo Then Opana2.8

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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. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo37.9
Opana Then Placebo Then Darvocet98.4
Placebo Then Opana Then Darvocet38.0
Placebo Then Darvocet Then Opana44.1
Darvocet Then Opana Then Placebo37.0
Darvocet Then Placebo Then Opana29.7

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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. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo2.8
Opana Then Placebo Then Darvocet2.8
Placebo Then Opana Then Darvocet3.1
Placebo Then Darvocet Then Opana2.6
Darvocet Then Opana Then Placebo3.3
Darvocet Then Placebo Then Opana2.6

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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. (NCT00652093)
Timeframe: study visit

Interventionminutes (Mean)
Opana Then Darvocet Then Placebo1.10
Opana Then Placebo Then Darvocet1.50
Placebo Then Opana Then Darvocet2.02
Placebo Then Darvocet Then Opana1.58
Darvocet Then Opana Then Placebo2.15
Darvocet Then Placebo Then Opana1.57

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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). (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo12.8
Opana Then Placebo Then Darvocet15.3
Placebo Then Opana Then Darvocet13.2
Placebo Then Darvocet Then Opana15.2
Darvocet Then Opana Then Placebo13.7
Darvocet Then Placebo Then Opana7.4

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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. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo2.5
Opana Then Placebo Then Darvocet2.5
Placebo Then Opana Then Darvocet2.6
Placebo Then Darvocet Then Opana2.6
Darvocet Then Opana Then Placebo2.6
Darvocet Then Placebo Then Opana2.2

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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. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo2.6
Opana Then Placebo Then Darvocet2.9
Placebo Then Opana Then Darvocet3.2
Placebo Then Darvocet Then Opana3.2
Darvocet Then Opana Then Placebo3.6
Darvocet Then Placebo Then Opana2.9

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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. (NCT00652093)
Timeframe: study visit

Interventionminutes (Mean)
Opana Then Darvocet Then Placebo1.73
Opana Then Placebo Then Darvocet3.02
Placebo Then Opana Then Darvocet3.93
Placebo Then Darvocet Then Opana2.65
Darvocet Then Opana Then Placebo0.83
Darvocet Then Placebo Then Opana5.43

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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. (NCT00652093)
Timeframe: study visit

Interventionmeters (Mean)
Opana Then Darvocet Then Placebo266.6
Opana Then Placebo Then Darvocet249.5
Placebo Then Opana Then Darvocet177.9
Placebo Then Darvocet Then Opana290.1
Darvocet Then Opana Then Placebo160.8
Darvocet Then Placebo Then Opana294.8

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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. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo51.3
Opana Then Placebo Then Darvocet57.9
Placebo Then Opana Then Darvocet56.2
Placebo Then Darvocet Then Opana46.7
Darvocet Then Opana Then Placebo63.3
Darvocet Then Placebo Then Opana55.1

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