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A randomized, placebo and active comparator (oxycodone)- controlled study on the effect of tapentadol on respiration and analgesia in healthy volunteers


- candidate number21661
- NTR NumberNTR5076
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-feb-2015
- Secondary IDs 
- Public TitleA randomized, placebo and active comparator (oxycodone)- controlled study on the effect of tapentadol on respiration and analgesia in healthy volunteers
- Scientific TitleA randomized, placebo and active comparator (oxycodone)- controlled study on the effect of tapentadol on respiration and analgesia in healthy volunteers
- ACRONYMthe Restiration study
- hypothesisAt equi-analgesia respiratory depression from oxycodone is manifold greater compared to Tapentadol
- Healt Condition(s) or Problem(s) studiedOpioids , Respiratory depression
- Inclusion criteriaAge of 18 to 45 years (inclusive);
Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive)
body weight between 50 kg and 100 kg (inclusive); Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
Subject is willing to comply with study restrictions
- Exclusion criteriaClinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator);
A semi recumbent systolic blood pressure of >160 mmHg and/or diastolic blood pressure of > 95 mmHg at screening;
History of alcoholism or substance abuse within three years prior to screening;
Positive pregnancy test;
Positive drug screening or alcohol breath test;
Subjects using more than 21 units of alcohol per week;
Use of medication during the study period;
If sexually active, the subject is not using contraceptives, or surgically sterilized;
Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
Participation in an investigational drug trial in the 2 months prior to administration of the initial dose of study drug or more than 5 times per year;
Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject:
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2015
- planned closingdate1-okt-2015
- Target number of participants12
- InterventionsHealthy volunteers will be administered Tapentadol in two doses, oxycodone or placebo. Hypercapnic ventilatory response curves will be obtained as well as pain pressure tests
- Primary outcomerepsiratory depression
- Secondary outcomepain pressure treshold
- Timepoints6 respiratory measurements will be obtained lasting 30 minutes at 1 hour intervals. pain tests will be obtained every half hour following administration of the study drug.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Grunenthal GmbH, Aachen Germany
- PublicationsNA
- Brief summaryTapentadol is a centrally acting analgesic with two mechanisms of action: a μ-opioid receptor agonism and noradrenaline (NA) reuptake inhibition. Although the binding of tapentadol to the μ-opioid receptor is weaker than that of morphine its analgesic action is similar to that of morphine due to the (synergistic) effect of the second mechanism (i.e., NA reuptake inhibition). As the effects on of opioid analgesics are attributed to μ-opioid receptor agonism, tapentadol should produce less respiratory depression at equi-analgesic doses.
- Main changes (audit trail)Addendum: 1-jun-2017 MT
Sample size analysis was performed on an estimated magnitude of decrease in ventilation at a fixed end-tidal PCO2 of 50% between oxycodone and tapentadol 100 mg, assuming equivalence in analgesic effect between the two drugs at these dosages. Assuming a difference in ventilatory depression of 5 L/min with a SD of 3.5 L/min, a power of 90% and an alpha of 0.05 results in a sample size of 12. This analysis was performed in SigmaPlot V12.5. However, since these are assumptions, we will perform an interim analysis after 50% completion of the study to assess whether adjustments to the subject number is required.

The interim analysis yielded the following: The effect size of ΔVE55 was 4 L min-1 with SD 4 L min-1. Fifteen subjects rather than 12, as earlier suggested in trialregister.nl, were required to detect a difference of this magnitude, with α = 0.5 and 1-β ≥ 0.9.
- RECORD6-feb-2015 - 1-jun-2017


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