NCT00338481

Brief Summary

The purpose of this study is to test whether "red morphine drops" applied in the mouth are superior to an equivalent amount of morphine applied as subcutaneous injection for the relief of breathlessness in terminal patients suffering from primary lung cancer or lung metastases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 27, 2011

Status Verified

February 1, 2011

Enrollment Period

4.8 years

First QC Date

June 16, 2006

Last Update Submit

July 26, 2011

Conditions

DyspneaLung Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Dyspnea on a VAS scale

    1 hour

Secondary Outcomes (1)

  • Respiratory rate, pulse rate, oxygen saturation

    1 hour

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Morphine p.o.

2

ACTIVE COMPARATOR
Drug: Morphine s.c.

Interventions

Morphine p.o.DRUG

Morphine p.o. in "red morphine drops" calculated as 1/12 of the 24 hours opioid consumption converted to morphine p.o., max. 24 mg morphine p.o.and isotonic sodium chloride s.c.

1
Morphine s.c.DRUG

False "red morphine drops" without morphine p.o. and 60% of 1/12 of the 24 hours opioid consumption converted to morphine p.o. but given s.c., max. 14,4 mg

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary lung cancer or lung metastases and
  • Moderate to severe dyspnea at rest (VAS equal to or more than 30)

You may not qualify if:

  • Causal treatment of dyspnea possible and indicated
  • Not receiving opioids on a regular basis
  • Methadone treatment
  • Intolerance to morphine
  • Without understanding of patient information
  • Depressed consciousness
  • Oxygen treatment, if changed with-in 20 min before start
  • Short-acting opioids with-in 4 h before start
  • Inhalation therapy for bronchodilation with-in 20 min before start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sankt Lukas Hospice

Copenhagen, Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

DyspneaLung Neoplasms

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Study Officials

  • Torben Krantz, Physician

    Sankt Lukas Hospice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

April 1, 2006

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 27, 2011

Record last verified: 2011-02

Locations

DK(1)