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The effect of tianeptine (antidepressant) on the respiratory depression caused by painkillers


- candidate number15305
- NTR NumberNTR4134
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-aug-2013
- Secondary IDsNL45511.058.13 P13.141
- Public TitleThe effect of tianeptine (antidepressant) on the respiratory depression caused by painkillers
- Scientific TitleA proof of concept study on the effect of tianeptine on opioidinduced respiratory depression
- ACRONYMSTORD
- hypothesisIt is hypothesized that tianeptine will prevent alfentanil‐induced respiratory depression without affecting antinociception.
- Healt Condition(s) or Problem(s) studiedRespiratory depression, Pain killers, Opioids , Alfentanil, Respiratory stimulant, Tianeptine
- Inclusion criteriaHealhty volunteers (male/female)
- Age of 18 to 35 years (inclusive);
- Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive) and 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 criteria-Clinically 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;
- Subjects using more than 20 units of alcohol per week;
- Use of medication during the study period;
- If sexually active, the subject is not using oral 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
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2013
- planned closingdate1-mei-2014
- Target number of participants16
- InterventionsIntravenous administration of Alfentanil by target cointrolled infusion (set to achieve a concentration of 100 ng/ml for 2 hours Oral dose of tianeptine
- Primary outcomeTo assess the respiratory effects of an oral dose of tianeptine on alfentanil-induced respiratory depression
- Secondary outcomeTo assess the antinociceptive effects of an oral dose of tianeptine during alfentanil infusion
- TimepointsAlfentanil blood samples: baseline, 20, 50, 80, 120, 150 minutes
Vi-CO2 response baseline, after tianeptine/placebo administration, twice following start alfentanil administration (combined with tianeptine/placebo) and after stop alfentanil administration Pain tests: (electrical and pain pressure) baseline, after tianeptine administration, twice following start alfentanil administration (combined with tianeptine/placebo) and after stop alfentanil administration
- Trial web siteN/A
- 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)
Revive therapeutics
- PublicationsN/A
- Brief summaryA double-blind, cross-over trial in 32 healthy volunteers to determine the influence of tianeptine (anti-depressant) on alfentanil-induced respiratory depression and analgesia
- Main changes (audit trail)10-jan-2015: Amendment:
- 16 extra participants, new target number of participants: 32 subjects
- Interventions:
a. group 1: crossover 8 subjects 37.5 mg Tianeptine/Placebo with 100 ng/ml TCI Alfentanil
b. group 2: crossover 8 subjects 50 mg Tianeptine/Placebo with 100 ng/ml TCI Alfentanil
c. group 3: crossover 8 subjects 100 mg Tianeptine/Placebo with 50 ng/ml TCI Alfentanil
d. group 4: crossover 8 subjects 100 mg Tianeptine/Placebo with 100 ng/ml TCI Alfentanil - AB
- RECORD21-aug-2013 - 10-jan-2015


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