interventional
N/A
1 country
3
The main object of the study is to examine the effect of 4 weeks treatment with slow-release morphine compared to placebo on the perception of breathlessness in patients with fibrotic interstitial lung diseases.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 22, 2023
Actual (reported)The change in average VAS score for dyspnea the last 24-hours (baseline) measured over a week and after 4 weeks treatment with morphine.
Change in walking distance during 6-minute walk test from baseline to follow-up after 4 weeks of treatment
Change in level of desaturation at 6-minute walk test from baseline to follow-up after 4 weeks of treatment
Change in BORG dyspnea scale at 6-minute walk test from baseline to follow-up after 4 weeks of treatment
Change in questionnaire (VAS for tough, Leicester Cough Questionnaire, King's Brief Lung Disease Questionnaire, COPD assessment Score) from baseline to follow-up after 4 weeks of treatment
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Malfin, depottabletter
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE TABLET
View registry recordFormulated product
Contalgin, depottabletter
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE TABLET
View registry recordFormulated product
Contalgin, depottabletter
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE TABLET
View registry recordFormulated product
MST CONTINUS 5 mg prolonged-release tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Malfin, depottabletter
Named ingredient: Morphine sulfate
View registry recordContalgin, depottabletter
Named ingredient: Morphine sulfate
View registry recordContalgin, depottabletter
Named ingredient: Morphine sulfate
View registry recordMST CONTINUS 5 mg prolonged-release tablets
Named ingredient: Morphine sulfate
View registry recordRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Aarhus University Hospital
Aarhus N, 8200, Denmark
Odense University Hospital
Odense C, 5000, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Sissel Kronborg-White
First Submitted
November 22, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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