Peripheral NeuropathyPhase 4NCT01458015

Tapentadol Versus Oxycodone - a Mechanism-based Treatment Approach in Neuropathic Pain

A Phase 4 study testing tapentadol, oxycodone in people with Peripheral Neuropathy, run by University Hospital Schleswig-Holstein at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e. reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain signs and symptoms in comparison to oxycodone. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Neuropathy
What is being tested?: tapentadol, oxycodone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteGermany
Study dates: Oct 2011to Nov 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

thermal or mechanical hyperalgesia
chronic neuropathic pain (NRS => 6)

Who cannot join

non-specific

Trial locations and contacts

1 site in 1 country.

Germany1 site

Division for Neurological Pain Research and Therapy
Kiel, Schleswig-Holstein, 24105

Other trials in Germany

About this study

Official title: Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain

Conditions: Peripheral Neuropathy
Being tested: tapentadol, oxycodone
Keywords: QST (quantitative sensory testing), neuropathic pain, tapentadol pr, oxycodone
Medical subject headings: Peripheral Nervous System Diseases, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tapentadol, oxycodoneDrug
Also called Palexia
tapentadol pr 100-500 mg oxycodone cr 20-120mg

Study groups in NCT01458015
Study group	Role	What they receive
oxycodone	Active comparator	Not described Receives: Drug: tapentadol, oxycodone
tapentadol	Active comparator	Not described Receives: Drug: tapentadol, oxycodone

What is being measured

The primary outcome is the main question the study is designed to answer.

Mechanical Pain Threshold (MPT)
Change of Mechanical Pain Threshold from baseline to V6 The mechanical pain threshold (MPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.) A lower z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)
Heat Pain Threshold (HPT)
Change of Heat Pain Threshold from V1 to V6 The was Heat Pain Threshold (HPT)measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.) A lower z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (10 weeks)
Wind-Up Ratio (WUR)
Change of Wind-Up Ratio from V1 to V6 The Wind-Up Ratio (WUR) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.) A lower z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (10 weeks)
Cold Pain Threshold (CPT)
Change of Cold Pain Threshold from baseline to V6 The Cold Pain Threshold (CPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.) A lower z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (10 weeks)
Pressure Pain Threshold (PPT)
Change of Pressure Pain Threshold from V1 to V6 The Pressure Pain Threshold (PPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.) A lower z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)
Mechanical Pain Sensitivity (MPS)
Change of Mechanical Pain Sensitivity from V1 to V6 The Mechanical Pain Sensitivity (MPS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.) A lower z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)
Dynamic Mechanical Allodynia (DMA)
Change of Dynamic Mechanical Allodynia from V1 to V6 The Dynamic Mechanical Allodynia (DMA) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). "Subjects were asked to give a pain rating for each stimulus on a '0-100' numerical rating scale ('0' indicating "no pain", and '100' indicating "most intense pain imaginable")." See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
A lower score indicates an improvement.
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)
Pain Upon Numeric Rating Scale
Change of pain upon Numeric Rating Scale (NRS; 0 = no pain at all; 10 = maximum pain imaginable) from V1 to V6
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)

Secondary outcomes (6)

Cold Detection Threshold (CDT)
Change of Cold Detection Threshold from V1 to V6 The Cold Detection Threshold (CDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.). A higher z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (10 weeks)
Warmth Detection Threshold (WDT)
Change of Warmth Detection Threshold from V1 to V6 The Warmth Detection Threshold (WDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.). A higher z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)
Thermal Sensory Limen (TSL)
Change of Thermal Sensory Limen from V1 to V6 The Thermal Sensory Limen (TSL) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Logarithmically trasnformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.). A higher z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)
Mechanical Detection Threshold (MDT)
Change of Mechanical Detection Threshold from V1 to V6 The Mechanical Detection Threshold (MDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.). A higher z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)
Vibration Detection Threshold (VDT)
Change of Vibration Detection Threshold from V1 to V6 The Vibration Detection Threshold (VDT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement.
(also see Rolke et. al.). A higher z-value indicates an improvement.
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)
Paradoxical Heat Sensations (PHS)
Change of Number of Paradoxical Heat Sensations from V1 to V6 The number of Paradoxical Heat Sensations (PHS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231.
An occurence of up to three paradoxical heat sensations was possible. The number was assessed. A lower number indicates an improvement.
Measured: day 0 (baseline) and day 78 (V6; 10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Nov 2013

First posted24 Oct 2011 (estimated)
Study startOct 2011
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral NeuropathyStudies 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01458015
Sponsor's protocol ID: TapOxy01
Status last verified: Dec 2024
First submitted: 5 Aug 2011
Last updated: 7 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
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Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis

All Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain
ClinicalTrials.gov ID: NCT01458015
Acronym / sponsor ID: TapOxy01
Conditions: Peripheral Neuropathy
Keywords: QST (quantitative sensory testing), neuropathic pain, tapentadol pr, oxycodone
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 3 participants (actual)
Lead sponsor: University Hospital Schleswig-HolsteinUniversity, hospital or other
Study start: Oct 2011
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 24 Oct 2011 (estimated)
Results: Posted 17 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
oxycodone	Active comparator	Drug: tapentadol, oxycodone
tapentadol	Active comparator	Drug: tapentadol, oxycodone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

thermal or mechanical hyperalgesia
chronic neuropathic pain (NRS => 6)

Key exclusion criteria (1 listed)

non-specific

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
tapentadol, oxycodoneAlso: Palexiatapentadol pr 100-500 mg oxycodone cr 20-120mg	Drug	oxycodone, tapentadol

Primary outcome

Mechanical Pain Threshold (MPT)
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of Mechanical Pain Threshold from baseline to V6 The mechanical pain threshold (MPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Heat Pain Threshold (HPT)
Time frame: day 0 (baseline) and day 78 (10 weeks)
Change of Heat Pain Threshold from V1 to V6 The was Heat Pain Threshold (HPT)measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Wind-Up Ratio (WUR)
Time frame: day 0 (baseline) and day 78 (10 weeks)
Change of Wind-Up Ratio from V1 to V6 The Wind-Up Ratio (WUR) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Cold Pain Threshold (CPT)
Time frame: day 0 (baseline) and day 78 (10 weeks)
Change of Cold Pain Threshold from baseline to V6 The Cold Pain Threshold (CPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Pressure Pain Threshold (PPT)
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of Pressure Pain Threshold from V1 to V6 The Pressure Pain Threshold (PPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Mechanical Pain Sensitivity (MPS)
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of Mechanical Pain Sensitivity from V1 to V6 The Mechanical Pain Sensitivity (MPS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Dynamic Mechanical Allodynia (DMA)
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of Dynamic Mechanical Allodynia from V1 to V6 The Dynamic Mechanical Allodynia (DMA) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). "Subjects were asked to give a pain rating for each stimulus on a '0-100' numerical rating scale ('0' indicating "no pain", and '100' indicating "most intense pain imaginable")." See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. A lower score indicates an improvement.
Pain Upon Numeric Rating Scale
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of pain upon Numeric Rating Scale (NRS; 0 = no pain at all; 10 = maximum pain imaginable) from V1 to V6

6 secondary outcomes

Cold Detection Threshold (CDT)
Time frame: day 0 (baseline) and day 78 (10 weeks)
Warmth Detection Threshold (WDT)
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Thermal Sensory Limen (TSL)
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Mechanical Detection Threshold (MDT)
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Vibration Detection Threshold (VDT)
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)
Paradoxical Heat Sensations (PHS)
Time frame: day 0 (baseline) and day 78 (V6; 10 weeks)

Results and safety

Results posted to the registry on 17 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tapentadol	2	2
Oxycodon Retard	1	0

Primary outcome: Mechanical Pain Threshold (MPT)

Time frame: day 0 (baseline) and day 78 (V6; 10 weeks). Mean (Full Range). Unit: Z-score

Measure	Oxycodone n = 1	Tapentadol n = 2
V1	1.1 (1.1 to 1.1)	2.6 (2.2 to 3)
V6	–	0.55 (-1.9 to 3)

Population analysed: Due to low number of participants only descriptive data is available

Primary outcome: Heat Pain Threshold (HPT)

Time frame: day 0 (baseline) and day 78 (10 weeks). Mean (Full Range). Unit: Z-score

Measure	Tapentadol n = 2	Oxycodone n = 1
V1	-0.5 (-1.8 to 2.8)	-0.2 (-0.2 to -0.2)
V6	-1.4 (-1.9 to -0.9)	–

Population analysed: Due to low number of participants only descriptive data is available

Primary outcome: Wind-Up Ratio (WUR)

Time frame: day 0 (baseline) and day 78 (10 weeks). Mean (Full Range). Unit: Z-score

Measure	Tapentadol n = 2	Oxycodone n = 1
V1	-0.6 (-0.8 to -0.4)	-0.2 (-0.2 to -0.2)
V6	0.75 (-0.6 to 2.1)	–

Population analysed: Due to low number of participants only descriptive data is available

Primary outcome: Cold Pain Threshold (CPT)

Time frame: day 0 (baseline) and day 78 (10 weeks). Mean (Full Range). Unit: Z-score

Measure	Tapentadol n = 2	Oxycodone n = 1
V1	0.35 (-1.2 to 1.9)	-1.1 (-1.1 to -1.1)
V6	0.35 (-1.2 to 1.9)	–

Population analysed: Due to low recruitement numbers only descriptive data is available

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tapentadol Retard	0 of 2 (0%)	2 of 2 (100%)	Not reported
Oxycodon Retard	0 of 1 (0%)	1 of 1 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ralf Baron, Prof. Dr. principal investigator

Head of Unit of Neuropathic Pain Research and Therapy, Department of Neurology, University Clinic Kiel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tapentadol, oxycodone in people with Peripheral Neuropathy, run by University Hospital Schleswig-Holstein at 1 site in Germany.

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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mechanical Pain Threshold (MPT) (time frame: day 0 (baseline) and day 78 (V6; 10 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01458015.

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 7 Jan 2025.