Morphine drops for rapid treatment of breathlessness in patients with cancer in incurable phase of the disease.

Oral morphine drops for rapid treatment of dyspnea in palliative cancer patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004380-37-DK

Enrollment

Unknown

Registered

2016-02-11

Start date

2016-05-03

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morphine drops for palliation of breathlessness in palliative cancer patients

Interventions

Trade Name: Oramorph Pharmaceutical Form: Oral drops INN or Proposed INN: Oramorph Other descriptive name: MORPHINE SULFATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cancerpatients in stable phase of the disease, performance status 0-2 Patients with breathlessness more than 1 on EORTC-QLQ-C15-PAL and 3 or more than 3 on questionaire ESAS Hemoglobin more than 6 and no tranfusion needed Are the trial subjects under 18? no 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: Known allergy or intolerence against morphine or other opioids Testpatients recieving chemo- or radiation therapy less than 7 days before inclusion Impaired renal funktion (GFR<50)

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to analyse how fast morphine drops in two wellknown formulates palliate breathlessness in cancer patients;Secondary Objective: To analyse changes in saturation, respiration frequens and pulse after 2 minute walk test and administration of test medicine.;Primary end point(s): Subjective palliation of breathlessness after 2 MWT(Minute Walk Test) and administration of test medicine;Timepoint(s) of evaluation of this end point: 5,10,15,20 and 30 minutes	—

Measure

Time frame

Main Objective: The aim of the study is to analyse how fast morphine drops in two wellknown formulates palliate breathlessness in cancer patients;Secondary Objective: To analyse changes in saturation, respiration frequens and pulse after 2 minute walk test and administration of test medicine.;Primary end point(s): Subjective palliation of breathlessness after 2 MWT(Minute Walk Test) and administration of test medicine;Timepoint(s) of evaluation of this end point: 5,10,15,20 and 30 minutes

—

Secondary

Measure	Time frame
Secondary end point(s): Saturation, respiration frequens and pulse rate;Timepoint(s) of evaluation of this end point: 5,10,15,20 and 30 minutes	—

Countries

Denmark

Contacts

Public ContactBirgit Åbom

University Hospital Sjaelland, Roskilde, Palliative Unit

bimaa@regionsjaelland.dk004547325083

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026