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Assessment of normal release morphine in the management of dyspnoea

Assessment of normal release morphine in the management of dyspnoea

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004620-12-GB
Enrollment
30
Registered
2005-02-17
Start date
2005-01-14
Completion date
Unknown
Last updated
2020-07-20

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

Conditions

Breathlessness of any cause in cancer patients are identified and treated with normal release morphine which has been shown to be both effective and safe.The idea of the trial is to see if there will be an added benefit to gentle dose increments. There are no placebos used.

Interventions

Product Name: diamorphine Product Code: 4543/0303 Pharmaceutical Form: Solution for injection Concentration unit: mg milligram(s) Concentration type: equal Product Name: oramorph oral solution Produc

Sponsors

Royal Marsden Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? A score of equal or more than 3 on the Modified Borg scale at rest ? Cancer diagnosis ? Inpatient at The Royal Marsden Hospital ? Aged over 18 years 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ?A score for breathlessness of less than 3 on the Modified Borg scale at rest ?Non cancer diagnosis ?Cognitive impairment ?Planned therapeutic procedure / anticancer treatment for breathlessness during the trial time. ?Patients taking opioids for moderate to severe pain e.g morphine, fentanyl, oxycodone. ?Aged under 18 years

Design outcomes

Primary

MeasureTime frame
Main Objective: The aim of this study is to investigate the effect of dose titration of morphine on patients who are dyspnoeic. Primary objective: To determine if a titrated increase in normal release morphine leads to a corresponding improvement in dyspnoea ;Secondary Objective: •To determine if there is a ceiling effect to the benefits of morphine on dyspnoea •To see if patients tolerate titration of morphine for dyspnoea. •To see if patients anxiety levels decrease if dyspnoea improves ;Primary end point(s): to identify the dose that best treats the symptoms of shortness of breath

Countries

United Kingdom

Outcome results

None listed

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