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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2005-005950-33-SE
Date of registration: 10/04/2006
Prospective Registration: Yes
Primary sponsor: Karolinska Universitetssjukhuset
Public title: Studie av Domperidon och barn med kongenitalt centralt hypoventilationssyndrom. - DOMPCCHSSWE1
Scientific title: Studie av Domperidon och barn med kongenitalt centralt hypoventilationssyndrom. - DOMPCCHSSWE1
Date of first enrolment: 07/06/2006
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: Double blind: Parallel group: Cross over: yes Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Countries of recruitment
Key inclusion & exclusion criteria
Inclusion criteria:
1. Patienter med congenital central hypoventilation syndrome, CCHS.
2. Ålder = 28 dagar och = 65 år.
3. Föräldrarna har samtyckt till att barnen deltar i denna studie.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exklusionskriterier motsvarar kontraindikationerna för behandling med Domperidon:

1 överkänslighet/allergi mot Domperidon
2 om stimulering av magsäckens motilitet bör undvikas, exempelvis vid gastrointestinal blödning, obstruktion eller perforation.
3 känt prolaktinom
4. Samtidig administration av oral ketokonazol (ketokonazol hämmar CYP3A4 som metaboliserar en stor del av Domperidon)
5. ej intakt blod-hjärnbarriär
6. risk för graviditet

Vi kommer även överväga att exkludera en patient med leverdysfunktion (Domperidon metaboliseras i levern) och allvarlig njursvikt, alternativt reducera läkemedelsdosen.

Age minimum:
Age maximum:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Congenital central hypoventilation syndrome, CCHS or Ondine's curse.

Trade Name: Motilium
Product Name: Motilium
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Domperidone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)
Main Objective: Studera om Domperidone/Motilium förbättrar andningsregleringen hos patienter med congenital central hypoventilation syndrome.
Primary end point(s): Andningsreglering/ Andas patienten mer effektivt med hjälp av Domperidon?:

1. Antal andningsuppehåll/apnéer?
2. Andetagsfrekvens och -volym
3. Respons vid CO2-test (hyperkapni, 4% CO2)
4. Respons vid O2-test (hyperoxitest, 100% O2)
5. Respons vid apnétest (när man stänger av/kopplar ur respirator/BiPAP)
6. Kan ett mindre invasivt andningunderstöd användas? ja/nej
7. Transkutana värden av CO2 och O2 under längre tid.

Sammantagen bedömning.
Secondary Objective: Undersöka om Domperidon har positiva effekter på eventuell esofagalreflux och andra gastrointestinala symtom på denna patientgrupp.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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