DyspneaPhase 4NCT00338481
"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer
A Phase 4 study testing Morphine p.o. and Morphine s.c. in people with Dyspnea and Lung Neoplasms, run by Sankt Lukas Hospice at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Lung Neoplasms
- What is being tested?
- Morphine p.o. and Morphine s.c.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2006to Feb 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary lung cancer or lung metastases and
- Moderate to severe dyspnea at rest (VAS equal to or more than 30)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Terminal Patients With Primary Lung Cancer or Lung metastases-a Pilot Study
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.
Read the detailed description
Breathlessness or dyspnea in terminal cancer patients with lung cancer is common and opioids such as morphine is the mainstay of symptomatic treatment. Subcutaneous administration of morphine provides fast symptomatic relief, but it has been the impression in our institution that "red morphine drops" applied orally may have equal or better efficacy and faster onset time.
Comparison: Patients with lung cancer or lung metastases with moderate to severe dyspnea at rest are treated with either orally applied "red morphine drops" or an equivalent amount of morphine applied subcutaneously.
- Conditions
- Dyspnea, Lung Neoplasms
- Being tested
- Morphine p.o., Morphine s.c.
- Medical subject headings
- Dyspnea, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Morphine p.o. |
| 2 | Active comparator | Not described Receives: Drug: Morphine s.c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea on a VAS scale
Measured: 1 hour
Secondary outcomes (1)
Respiratory rate, pulse rate, oxygen saturation
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startApr 2006
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sankt Lukas Hospice
- Sponsor type
- University, hospital or other
- Investigators
- Torben Krantz, Physician, Principal investigator, Sankt Lukas Hospice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338481
- Sponsor's protocol ID
- 2005-060-version1a
- Status last verified
- Feb 2011
- First submitted
- 16 Jun 2006
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Terminal Patients With Primary Lung Cancer or Lung metastases-a Pilot Study
- ClinicalTrials.gov ID
- NCT00338481
- Acronym / sponsor ID
- 2005-060-version1a
- Conditions
- Dyspnea, Lung Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sankt Lukas HospiceUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breathlessness or dyspnea in terminal cancer patients with lung cancer is common and opioids such as morphine is the mainstay of symptomatic treatment. Subcutaneous administration of morphine provides fast symptomatic relief, but it has been the impression in our institution that "red morphine drops" applied orally may have equal or better efficacy and faster onset time.
Comparison: Patients with lung cancer or lung metastases with moderate to severe dyspnea at rest are treated with either orally applied "red morphine drops" or an equivalent amount of morphine applied subcutaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Morphine p.o. |
| 2 | Active comparator | Drug: Morphine s.c. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary lung cancer or lung metastases and
- Moderate to severe dyspnea at rest (VAS equal to or more than 30)
Key exclusion criteria (9 listed)
- Causal treatment of dyspnea possible and indicated
- Not receiving opioids on a regular basis
- Methadone treatment
- Intolerance to morphine
- Without understanding of patient information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine p.o.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. | Drug | 1 |
| Morphine s.c.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 | Drug | 2 |
Primary outcome
Dyspnea on a VAS scale
Time frame: 1 hour
1 secondary outcome
Respiratory rate, pulse rate, oxygen saturation
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torben Krantz, Physician principal investigator
Sankt Lukas Hospice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine p.o. and Morphine s.c. in people with Dyspnea and Lung Neoplasms, run by Sankt Lukas Hospice at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea on a VAS scale (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2011.