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Respiratory study determing the utility of respiratory stimulants in healty volunteerds.


- candidate number12943
- NTR NumberNTR3500
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jun-2012
- Secondary IDsP12.084 / 2012-001849-41; LUMC / EudraCT
- Public TitleRespiratory study determing the utility of respiratory stimulants in healty volunteerds.
- Scientific TitleTwo-part Randomized, Placebo-controlled, Repeated Stepped Infusion Dose study of the Pharmacodynamics of Doxapram when co-administered with Opioids.
- ACRONYMDOXA-101
- hypothesisDevelopment and validation of a clinical Proof-of-Concept study paradigm for determing the clinical utility of respiratory stimulants over the potential therapeutic dose range in the face of opioid respiratory depression and presences of hypercapnia.
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteriaHealty volunteers in the age of 18-45 with a BMI between 18-30 kg/mm2. There has to be no ECG abnormalities, no clinical laboratory abnormalities, no clinically significant disease. All subjects must sign the written informed consent.
- Exclusion criteriaHistory of: Alcohol abuse, anxiety disorder, psychiatric diseases, drug abuse, smoking,bleeding disorders, medical history. allergic reactions, malignancy, malignant hyperthermia.
Other exclusion criteria is family members or allergic reactions.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-jul-2012
- planned closingdate1-nov-2012
- Target number of participants18
- Interventions8-16 volunteers will be included in Part 1.
In part 1 they will participate during 4 study days. In 2 study days their EtCO2 will be clamped, in 2 study days there will be ambient air and pain measurements will be performed. All 4 study days they will receive Alfentanil in 2 different doses, 2 days they will receive Doxapram in 2 different doses or a placebo.
In Part 2 6-10 patients will be included depended on the results of part 1. During part 2 the patients will receive two doses of Doxapram without Alfentanil.
Furthermore we will measure cardiac output during both parts.
- Primary outcome1. Determine the respiratory response of low and high doses of doxapram in conjunction with a low dose of opioids in healty volunteers;
2. Determine the respiratory response of low and high doxapram in conjunction with a low dose of opioids and hypercapnia in healty volunteers.
- Secondary outcome1. Determine the respiratory response of low and high doses of doxapram in conjunction with a high dose of opioids in healty volunteers;
2. Evaluate the tolerability of doxapram in conjunction with a low and high dose of opioids in healty volunteers;
3. Evaluate the PK-PD relationship of the respiratory responses of Doxapram in conjunction with a low and high dose of opioids in healty volunteers.
- TimepointsPart 1:
Ventilatory assessments: Every 30 min;
Blood Sample: 28 samples for Alfentanil, 15 samples for Doxapram;
Subjects sedation scale: Every 30 min;
Heartrate, saturation and CO will be measured continously.

Part 2:
Ventilatory assessments: Every 30 min;
Blood Sample: 17 samples for Doxapram;
Subjects sedation scale: Every 30 min;
Heartrate, saturation and CO will be measured continously.
- Trial web siteN/A
- statusopen: patient inclusion
- 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)
Galleon Pharmaceuticals
- PublicationsN/A
- Brief summaryA study to determine the utility of respiratory stimulants with and without opioid therapy and with hypercapnia or ambient air.
- Main changes (audit trail)
- RECORD27-jun-2012 - 12-jul-2012


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