PainPhase 4NCT00357942
Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy
A Phase 4 study testing morphine solution for injection and morphine mouthwash in people with Pain and Mucositis, run by Danish University of Pharmaceutical Sciences at 1 site in Denmark.
Trial summary
Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- morphine solution for injection and morphine mouthwash
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Jan 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children and adolescents at The Juliane Marie Center at Copenhagen University Hospital (Rigshospitalet, Denmark) or at The University Hospital in Lund (Sweden)
- Receiving chemotherapy in relation to a cancer disease
- Pain score of minimum 3 (VAS-scale) at rest for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale) or a pain score of minimum 5 (VAS-scale) at activity for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale)
- Negative pregnancy test, when relevant (judged by physician)
- Patients and/or parents understand and speak danish (Denmark) / swedish (Sweden)
- Signed informed consent
Who cannot join
- Allergic to the investigational medical product
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)
Copenhagen, DK-2100
About this study
Official title: Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children
Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect.
The purpose of this study is to test the analgesic effect of a morphine mouthwash versus morphine injections or placebo (no active drug) in children/adolescents with stomatitis related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine injections) the children/adolescents receive a standardized analgesic treatment for stomatitis-related pain.
- Being tested
- morphine solution for injection, Placebo, morphine mouthwash
- Keywords
- Morphine, Mouthwash, Mucositis, Pain, Cancer, Child, Adolescent
- Medical subject headings
- Pain, Mucositis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphine solution for injectionDrug
morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash
PlaceboDrug
Placebo mouthwash
morphine mouthwashDrug
morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection
PlaceboDrug
Placebo solution for injection every 3 hour for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| C group I | Experimental | Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) Receives: Drug: morphine mouthwash; Drug: Placebo |
| C group II | Active comparator | Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) Receives: Drug: morphine solution for injection; Drug: Placebo |
| C group III | Placebo comparator | Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of supplemental analgesics
Measured: 24 hours
Secondary outcomes (5)
Pain score at rest
Measured: 24 hours
Pain score at activity (performance of oral hygiene)
Measured: 24 hours
Time to first dose of supplemental analgesics
Measured: 24 hours
Frequency and severity of side effects
Measured: 24 hours
Oral intake of food
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish University of Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences
- Investigators
- Bettina N Nielsen, PhD student M.Sc.Pharm, Study chair, Faculty of Pharmaceutical Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357942
- Sponsor's protocol ID
- 102010
- Other IDs
- 2006-003260-53, 2006-003260-53
- Status last verified
- Feb 2014
- First submitted
- 27 Jul 2006
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children
- ClinicalTrials.gov ID
- NCT00357942
- Acronym / sponsor ID
- 102010
- Keywords
- Morphine, Mouthwash, Mucositis, Pain, Cancer, Child, Adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Danish University of Pharmaceutical SciencesUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Study start
- Sep 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Jul 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.
Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect.
The purpose of this study is to test the analgesic effect of a morphine mouthwash versus morphine injections or placebo (no active drug) in children/adolescents with stomatitis related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine injections) the children/adolescents receive a standardized analgesic treatment for stomatitis-related pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C group I | Experimental | Drug: morphine mouthwash, Drug: PlaceboMorphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) |
| C group II | Active comparator | Drug: morphine solution for injection, Drug: PlaceboPlacebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) |
| C group III | Placebo comparator | Drug: PlaceboPlacebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Children and adolescents at The Juliane Marie Center at Copenhagen University Hospital (Rigshospitalet, Denmark) or at The University Hospital in Lund (Sweden)
- Receiving chemotherapy in relation to a cancer disease
- Pain score of minimum 3 (VAS-scale) at rest for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale) or a pain score of minimum 5 (VAS-scale) at activity for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale)
- Negative pregnancy test, when relevant (judged by physician)
- Patients and/or parents understand and speak danish (Denmark) / swedish (Sweden)
Key exclusion criteria (2 listed)
- Allergic to the investigational medical product
- Alcohol or drug abuse
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 solution for injectionmorphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash | Drug | C group II |
| PlaceboPlacebo mouthwash | Drug | C group II, C group III |
| morphine mouthwashmorphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection | Drug | C group I |
| PlaceboPlacebo solution for injection every 3 hour for 24 hours | Drug | C group I, C group III |
Primary outcome
Use of supplemental analgesics
Time frame: 24 hours
5 secondary outcomes
Pain score at rest
Time frame: 24 hours
Pain score at activity (performance of oral hygiene)
Time frame: 24 hours
Time to first dose of supplemental analgesics
Time frame: 24 hours
Frequency and severity of side effects
Time frame: 24 hours
Oral intake of food
Time frame: 24 hours
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 21 Feb 2014.
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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.
Bettina N Nielsen, PhD student M.Sc.Pharm study chair
Faculty of Pharmaceutical Sciences, University of Copenhagen
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 solution for injection and morphine mouthwash in people with Pain and Mucositis, run by Danish University of Pharmaceutical Sciences 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 6 inclusion and 2 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 21 Feb 2014. 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. Some participants in this study may receive a placebo. 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?
Use of supplemental analgesics (time frame: 24 hours). 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 21 Feb 2014.